Systems and methods for fusing a sacroiliac joint and anchoring an orthopedic appliance

ABSTRACT

An orthopedic anchoring system for attaching a spinal stabilization system and concomitantly fusing a sacroiliac joint is disclosed that includes a delivery tool and an implant assembly for insertion into a joint space of a sacroiliac joint. The implant assembly may be secured using anchors inserted through bores within the implant body and into the underlying sacrum and/or ilium. The implant body may also include an attachment fitting reversibly attached to a guide to provide attachment fittings for elements of the spinal stabilization system. The implant assembly may be releasably coupled to an implant arm of the delivery tool such that the implant arm is substantially aligned with the insertion element of the implant assembly. An anchor arm used to insert the anchor may be coupled to the implant arm in a fixed and nonadjustable arrangement such that the anchor is generally aligned with a bore within the implant assembly.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 14/660,784 (“the '784 application”), entitled“Systems and Methods for Fusing a Sacroiliac Joint and Anchoring anOrthopedic Appliance,” filed on Mar. 17, 2015, which claims the benefitof and priority to U.S. Provisional Patent Application 61/954,594,entitled “Systems and Methods for Fusing a Sacroiliac Joint andAnchoring an Orthopedic Device,” filed on Mar. 17, 2014, the contents ofwhich are incorporated herein by reference in their entirety.

The '784 application is also a continuation-in-part of InternationalApplication PCT/US2014/30889, entitled “Systems and Methods for Fusing aSacroiliac Joint and Anchoring an Orthopedic Appliance,” filed on Mar.17, 2014, which claims the benefit of and priority to U.S. ProvisionalPatent Application 61/798,225, entitled “Systems and Methods for Fusinga Sacroiliac Joint and Anchoring an Orthopedic Appliance,” filed on Mar.15, 2013, the contents of which are incorporated herein by reference intheir entirety. International Application PCT/US2014/30889 furtherclaims priority to U.S. Provisional Patent Application 61/859,134,entitled “Systems and Methods for Fusing a Sacroiliac Joint andAnchoring an Orthopedic Appliance,” filed on Jul. 26, 2013, the contentsof which are incorporated herein by reference in their entirety.

The '784 application is also a continuation-in-part of U.S. patentapplication Ser. No. 14/514,221 (hereinafter, “the '221 application”),entitled “Systems for and Methods of Preparing a Sacroiliac Joint forFusion,” filed on Oct. 14, 2014, which claims the benefit of andpriority to the following U.S. provisional patent applications: U.S.Provisional Patent Application 61/891,330, entitled “Systems for andMethods of Fusing a Sacroiliac Joint,” filed on Oct. 15, 2013; U.S.Provisional Patent Application 61/912,494, entitled “Systems for andMethods of Fusing a Sacroiliac Joint,” filed on Dec. 5, 2013; U.S.Provisional Patent Application 61/914,409, entitled “Systems for andMethods of Fusing a Sacroiliac Joint,” filed on Dec. 11, 2013; U.S.Provisional Patent Application 61/954,594, entitled “Systems and Methodsfor Fusing a Sacroiliac Joint and Anchoring an Orthopedic Appliance,”filed on Mar. 17, 2014; and U.S. Provisional Patent Application61/891,345, entitled “Systems for and Methods of Fusing a SacroiliacJoint,” filed on Oct. 15, 2013. Each of these applications is herebyincorporated herein by reference in its entirety.

The '784 application is also a continuation-in-part of U.S. patentapplication Ser. No. 14/447,612 (“the '612 application”), entitled“Systems for and Methods of Fusing a Sacroiliac Joint,” filed on Jul.31, 2014. The '221 application is also a continuation-in-part of the'612 application. The '612 application claims the benefit of andpriority to the following U.S. provisional applications: U.S.Provisional Patent Application 61/979,857, entitled “Sacroiliac JointImplant” and filed on Apr. 15, 2014; U.S. provisional application61/955,126, entitled “Sacroiliac Joint Implant” and filed on Mar. 18,2014; U.S. Provisional Patent Application 61/914,409, entitled “Systemsfor and Methods of Fusing a Sacroiliac Joint” and filed on Dec. 11,2013; and U.S. Provisional Patent Application 61/860,185, entitled“Systems for and Methods of Fusing a Sacroiliac Joint” and filed on Jul.30, 2013. The '612 application and all provisional patent applicationsto which it claims priority are hereby incorporated by reference intheir entireties into the present application.

The '784 application is also a continuation-in-part of U.S. patentapplication Ser. No. 14/567,956 (“the '956 application”), entitled“Implants, Systems, and Methods for Fusing a Sacroiliac Joint,” filedDec. 11, 2014. The '956 application is incorporated herein by referencein its entirety.

The present application incorporates herein by reference the contents ofeach of the following applications in each application's entirety: U.S.patent application Ser. No. 14/127,119, entitled “Sacroiliac JointImplant System,” filed on Dec. 17, 2013; U.S. patent application Ser.No. 13/946,790, entitled “Systems for and Methods of Fusing a SacroiliacJoint,” filed on Jul. 19, 2013; International ApplicationPCT/US2012/042823, entitled “Sacroiliac Joint Implant System,” filedJun. 15, 2012; U.S. patent application Ser. No. 13/475,695, entitled“Systems for and Methods of Fusing a Sacroiliac Joint,” filed on May 18,2012; U.S. patent application Ser. No. 13/236,411, entitled “Systems forand Methods of Fusing a Sacroiliac Joint,” filed on Sep. 19, 2011; U.S.Provisional Patent Application 61/520,956, entitled “Sacroiliac JointImplant System,” filed on Jun. 17, 2011; U.S. patent application Ser.No. 12/998,712, entitled “Sacroiliac Joint Fixation Fusion System,”filed on May 23, 2011; International Application PCT/US2011/000070,entitled “Sacroiliac Joint Fixation Fusion System,” filed on Jan. 13,2011; and U.S. Provisional Patent Application 61/335,947, entitled“Sacroiliac Joint Fusion System,” filed on Jan. 13, 2010.

FIELD OF THE INVENTION

Aspects of the present invention relate to medical apparatuses andmethods. More specifically, the present invention relates to devices andmethods for providing an anchoring attachment for a spinal stabilizationsystem and for concomitantly stabilizing, immobilizing, fixating orfusing a sacroiliac joint.

BACKGROUND OF THE INVENTION

Reinforcement, stabilization, replacement, reconstruction, or fusion ofa joint or vertebrae may be indicated as a treatment of an afflictedregion of a patient. Examples of specific treatments include spinalstabilization, spinal fusion, posterolateral spinal fusion, posteriorlumbar interbody fusion, transforaminal lumbar interbody fusion, lateralinterbody fusion, anterior lumbar interbody fusion, vertebralimmobilization or reinforcement, intervertebral joint immobilization orreinforcement, degenerative disk stabilization, repair of traumaticfracture dislocation of the pelvis, treatment of degenerative arthritis,treatment of sacroiliitis (an inflammation or degenerative condition ofthe sacroiliac joint), osteitis condensans ilii, and treatments of otherdegenerative conditions of joints or vertebrae or other musculoskeletalinjuries, diseases, conditions or disorders.

This reinforcement of intervertebral joints, sacroiliac joints, or otherjoint stabilizations may be accomplished by one or more existingmethods, including inserting stabilizing implants such as support rodsinto the afflicted regions. Typically these fusion implants span anafflicted joint and may be anchored to bone tissue on either side of theafflicted joint using existing orthopedic fasteners such as pediclescrews or other orthopedic anchoring devices. These existing fusionimplants may completely immobilize the afflicted joint or may allowlimited or unconstrained movement to approximate or permit the normalmovements of the afflicted joint.

One limitation of many existing fusion procedures involves the challengeof situating a fusion implant in suitably close alignment with theremoved tissues of the patient to achieve a stable fixation of the jointor vertebrae. Existing implant structures may have insufficientengagement with the articular surfaces or cortical bone of the joint foradequate fixation or fusion. This failure to sufficiently stabilize andfuse the joint with the conventional implant structures and methods mayresult in a failure to relieve the condition being treated.

Another limitation of the fusion and fixation implants and associatedanchors used in existing fusion procedures is the relatively largeprofile or prominence of the components. The large footprint of existingfusion implants and associated anchors necessitate the removal ofconsiderable bone and/or soft tissue to prepare the area for theinstallation of the implant, possibly resulting in considerablepost-operative pain. Further, the high profile or prominence of elementsof the fusion or fixation implant projecting away from the spine orpelvis may chronically irritate the soft tissues, resulting in chronicpain during long-term use of the fusion implant and may require furthersurgeries and explantation.

Additional limitations of existing fusion implants are also related tothe long-term use of the implants. Over time, the anchoring elementssuch as pedicle screws may loosen over time due to exposure to repeatedloads associated with movements of the patient, thereby reducing thestabilization provided by the implant. Even if more robust anchoringdevices or systems are used, the long-term use of these existing fusionimplants are associated with an increased chance of injury to one ormore joints adjacent to the reinforced joint.

The stabilization of afflicted lumbar intervertebral joints poses aparticular challenge with respect to surgical interventions. The lumbarintervertebral joints are particularly vulnerable to injury ordegradation because these joints bear the majority of the body's weightbut also effectuate about half of the body's overall flexion movements(forward-backward bending). As a result, a sizeable fraction of backpain symptoms are associated with injuries or degradation of the lumbarintervertebral joints, in particular the L3-L4 and L4-L5 joints.

Treatment of spinal pathologies, including scoliosis, using existinglumbosacral fusion or fixation implants may increase the patient's riskof complications including loosening of anchor elements, implant-inducedinjury of surrounding joints, and/or implant-induced injury or chronicirritation of soft tissues surrounding the implant as describedpreviously. Some existing lumbar fusion implants may provide additionalanchoring to the ilium and/or sacrum bones of the pelvic girdle toenhance the robustness of anchoring and/or structural support. However,anchoring a lumbar fusion implant to one or more bones of the pelvicgirdle presents additional risks of complications not yet completelyaddressed by existing implant systems or methods.

Due to the relatively dense concentrations of exposed nerves emergingfrom the sacrum region, the implantation of a transacrally fixed lumbarfusion implant is associated with an increased risk of nerve injuryduring implantation and/or chronic use of the implant. In addition, thebone tissue of the sacrum consists largely of lower density cancellousbone tissue, which is less structurally robust and therefore morevulnerable to anchor loosening relative to other bones. Lastly, theincreased loading applied to the sacrum via the attached lumbar fusionimplant may induce an accelerated degradation or failure of one or bothsacroiliac joints.

Other existing lumbosacral fusion or fixation implants may provideadditional anchors fixed to the ilium; the ilium contains a much higherproportion of higher-density cortical bone and therefore provides a morerobust anchoring surface than the sacrum. However, additional loadsinduced by an ilium-fixed lumbar fusion implant may induce anaccelerated degradation or failure of one or both sacroiliac joints.Although some existing lumbar fusion implants are anchored to both theilium and the sacrum, alterations to the chronic loading of thearticulating surfaces of the sacroiliac joints may induce accelerateddegradation or failure of one or both sacroiliac joints.

In the practice of orthopedic and neurologic surgery, while attemptingto correct a pathology of the spine by means of fixation orstabilization, strong forces can be concentrated on certain parts of thespine and pelvis. Specifically, the junction above or below a fixated orstabilized segment of the spine can undergo forces which can affecthealthy alignment of the spine, or portions of the pelvis such as thesacroiliac joint. Unhealthy alignment of anatomic structures involved insuch procedures can result in severe complications for example chronicsevere pain, permanent disability and paralysis. The complexity of thespinal reconstruction, the sagittal balance realignment, the number ofvertebrae involved, or other factors may increase the risk ofcomplications. In published literature morbidity rates near fiftypercent for such procedures. In order to minimize the forces a fixatedor stabilized segment of vertebrae can create, a conventional techniqueemploys the use of metal or plastic rods (or bands, cord, etc.) whichcan be configured to extend to a sacrum or ilium and screws insertedinto either or both bones or across both bones which can then connect tothe rods to help stabilize the spinal construct. Substantial problemswith conventional techniques exist which can significantly affect apatient's recovery from the surgery.

A significant problem with certain conventional methods for pelvicfixation including the procedure mentioned above is that there is atendency for the screws to pull out, loosen, break or otherwise causecomplications due to the strong forces which can be present. Anothersignificant problem with certain conventional methods for pelvicfixation including placement of a (S2 alar iliac (S2AI)) screw into thesecond sacral body (S2) which then crosses the sacroiliac joint(extra-articularly) and continues into the ilium extending across thecortical bone to better fixate the screw may be that the screw ispositioned such that it violates the articular portion of the sacroiliacjoint. Literature shows that this can occur up to 60% of the time. Dueto the high chances of trauma caused by the screw extending to thearticular portion of the joint, severe pain may result.

The inventive anchoring system for one or more elements of a spinalstabilization system described herein addresses the problems associatedwith conventional methods and apparatuses used to anchor one or moreelements of a spinal stabilization system.

BRIEF SUMMARY OF THE INVENTION

One implementation of the present disclosure may take the form of asacroiliac joint fusion implant assembly including an implant body andan anchor. The implant body may include an insertion element includingan elongate body with a proximal insertion element end and a distalinsertion element end, as well as an attachment element mechanicallyattached to the proximal insertion element end. The attachment elementincludes an anchor fitting formed within the attachment element ormechanically attached to the attachment element. The anchor fitting maybe configured to receive the anchor inserted within a predeterminedrange of anchor insertion trajectories.

In another implementation, the insertion element may be an insertionplate. The insertion plate may include a medial face, a lateral faceopposite to the medial face, and a first bore extending across andthrough the medial and lateral faces of the insertion element. The firstbore may extend to the distal insertion element end to define an opendistal end. The insertion plate may also include one or more elongatefins. Each of the one or more fins may project perpendicularly outwardfrom the medial face or the lateral face and may extend longitudinallybetween the proximal insertion element end and the distal insertionelement end. The fins and the insertion plate may taper toward a narrowinsertion plate leading edge. The insertion plate leading edge may beconfigured for insertion into the joint space of a sacroiliac joint.

The insertion plate may further include one or more additional bores.Each additional bore may include a bore cross-sectional profile and abore axis situated along the bore centerline. The bore centerline mayinclude a line connecting each additional bore's cross-sectional profilecentroids. Each additional bore may be situated on the medial face orlateral face and may be directed inward along the bore centerline, andeach additional bore may be configured to receive a distal end of anadditional orthopedic fastener. Each additional bore may be a blind boreextending partially through the insertion plate to the lateral face ormedial face in one implementation. In another implementation, eachadditional bore may an open bore extending through the insertion platefrom the lateral face to the medial face. One of the additional boresmay be configured to receive a distal end of the anchor projecting fromthe anchor fitting after insertion of the anchor into the anchor fittingwithin the predetermined range of anchor insertion trajectories. One ofthe additional bores may have a cross-sectional profile chosen from:square, rectangular, circular, oval, triangular and any combinationthereof.

In another implementation, the attachment element may be permanentlyattached at a fixed position and angle to the proximal end of theinsertion element. The angle formed between the attachment element andthe insertion element may range from about 30° to about 120°. Theattachment element and insertion element may be formed as a continuousstructure. The attachment element and insertion element may be attachedin a hinged attachment; the angle formed between the attachment elementand insertion element may range from about 30° to about 120°.

In another implementation, the anchor fitting may include a bore formedwithin the attachment element. The bore may an open bore passing from aproximal attachment element surface to a distal attachment elementsurface. The bore may have a cross-sectional profile chosen from:square, rectangular, circular, oval, triangular and any combinationthereof. The bore may be configured to allow the insertion of an anchorat any angle of up to about 45° relative to an axis perpendicular to aregion of the attachment element in close proximity to the bore.

The anchor fitting may be attached to an anchor support element of theattachment assembly and configured to receive an anchor within apreselected range of anchor insertion trajectories. The anchor supportelement may include a rectangular cross-sectional profile and the anchorfitting may include a channel with a rectangular cross-sectional contourmatched to the cross-sectional profile of the anchor support element;the anchor fitting may resist rotation about the axis of the anchorsupport. The anchor support element may include a circularcross-sectional profile and the anchor fitting may include an anchorfitting attachment bore with a circular cross-sectional contour matchedto the cross-sectional profile of the anchor support element. The anchorfitting may permits rotation about the axis of the anchor support.

The anchor may be chosen from: a cortical screw, a cancellous screw, anda Steffee screw. In one implementation the anchor may be a Steffee screwand the anchor support element may be a Steffee plate formed within theattachment element. In another implementation, the anchor may be adual-threaded bone screw that includes a head and a shaft. The shaft mayinclude a proximal threaded segment with a first threading pattern and adistal threaded segment with a second threading pattern.

In another implementation, the attachment element may also include anattachment fitting attached to a guide formed within the attachmentelement. The guide may include a guide bore configured to receive anattachment fitting that includes a head of a polyaxial pedicle screw.The distal end of the polyaxial screw may be inserted through the guidebore within a predetermined range of attachment fitting insertionangles. The head of the polyaxial pedicle screw may include at least twosides forming a lower surface of an upward-facing groove configured toreceive a rod and further forming a threaded fitting configured toreceive a locking nut.

In another implementation, the attachment fitting may include a slidingattachment fitting configured to translate within a guide slot formedwithin the attachment element. The guide slot may include an elongatehole passing through the attachment element and directed along a slotpathway. The slot pathway may be selected from any one or more of: astraight line, a curve, an arc, and any combination thereof. The guideslot may also include a raised edge projecting proximally from theproximal surface of the attachment element around a perimeter of theguide slot.

In an implementation, the sliding attachment fitting may include aproximal head including at least two sides forming a lower surface of anupward-facing groove configured to receive a rod and further forming athreaded fitting configured to receive a locking nut. The slidingattachment fitting may also include a shaft configured to slide withinthe guide slot; a first end of the shaft may be attached to the proximalhead opposite to the upward-facing groove. The sliding attachmentfitting may further include a distal contact surface attached at asecond end of the shaft opposite to the first end. The distal contactsurface and proximal head may be situated on opposite sides of theattachment element and connected by the shaft situated within the guidegroove.

The distal contact surface of the attachment fitting may include anessentially flat planar surface that restricts the rotation of theattachment fitting to essentially rotations about a shaft axis. Thedistal contact surface of the attachment fitting may include a curvedsurface that permits the rotation of the attachment fitting about axesperpendicular to the shaft axis.

In another implementation, the guide may include a guide rail and theattachment fitting may include a sliding attachment fitting configuredto translate along the guide rail. The sliding attachment fitting mayinclude a proximal head including at least two sides forming a lowersurface of an upward-facing groove configured to receive a rod andfurther forming a threaded fitting configured to receive a locking nut.The sliding attachment fitting may also include a transverse channelconfigured to receive the guide rail situated at a distal end of theattachment fitting opposite to the upward-facing groove. The guide railand the transverse channel may also include a rectangular cross-section;the guide rail may resist rotation of the attachment fitting in anydirection.

In another implementation, the sliding attachment fitting may alsoinclude: a proximal element forming the lower surface of theupward-facing groove at one end and forming an annular channel at anopposite end; and a distal element forming the transverse rectangularchannel at a first end and forming an annular flange at a second endopposite to the first end. The annular channel and the annular flangemay engage in a sliding rotational engagement to permit the rotation ofthe attachment fitting about an axis of rotation coincident with thecentral axis of the sliding attachment fitting. The guide rail and thetransverse channel may have circular cross-sectional profiles,permitting the attachment fitting to rotate about the axis of the guiderail.

Another implementation may take the form of a sacroiliac joint fusionimplant assembly including an implant body and one or more anchors. Theimplant body may include an insertion element having an elongatecylindrical body with a proximal insertion element end, a distalinsertion element end, and a threaded outer surface configured forinsertion into a joint space of a sacroiliac joint by twisting theinsertion element into a cylindrical receiving bore formed within thejoint space. Each of the one or more anchors may be configured forinsertion through one or more transverse bores formed within the implantbody.

In an implementation, the insertion element may further include anattachment fitting attached to the proximal insertion element end. Theinsertion element may also include an attachment element fastenerattached to the proximal insertion element end. The implant assembly mayalso include an attachment element fastened to the proximal insertionelement end at the attachment element fastener.

Another implementation may take the form of a sacroiliac joint fusionand anchoring system that includes an implant assembly and a deliverytool. The implant assembly may include an implant body including aninsertion element with an elongate body with a proximal insertionelement end and a distal insertion element end, as well as an attachmentelement mechanically attached to the proximal insertion element end. Theattachment element may include an anchor fitting formed within theattachment element or mechanically attached to the attachment element.The implant assembly may also include an anchor.

In this implementation, the delivery tool may include an implant armwith a distal implant arm end configured to releasably couple to theproximal insertion element end as well as an anchor arm including aproximal anchor arm end coupled to the implant arm and a distal anchorarm end opposite to the proximal anchor arm end. The distal anchor armend distally ends in a sleeve configured to guide the anchor within apredetermined range of anchor insertion trajectories. The sleeve isconfigured to guide the anchor through the anchor fitting within thepredetermined range of anchor insertion trajectories when the distalimplant arm end is releasably coupled to the proximal insertion elementend.

The insertion element may also include an attachment fitting formedwithin the proximal insertion element end. The attachment fitting isconfigured to receive a corresponding attachment fastener situatedwithin the distal end of the delivery tool. The attachment fitting maybe a threaded bore and the attachment fastener may be a screw. Theattachment fitting may also include one or more alignment featureschosen from: one or more additional threaded bores formed within theproximal insertion element end and separated by a lateral distance fromthe attachment fitting; and one or more alignment peg receptaclesconfigured to receive one or more corresponding alignment pegsprojecting distally from an extreme distal face of the delivery tool.

The alignment peg receptacles may be situated within a proximal surfaceof the attachment element within the lateral edge of the attachmentelement. The alignment peg receptacles may be inset within the lateraledge of the attachment element. The alignment pegs may be arranged in apattern corresponding to an edge contour of the lateral edge of theattachment element.

In one implementation, the sleeve of the anchor arm may include atubular guide with a proximal opening and a distal opening. The proximalopening is configured to receive a distal tip of the anchor or otherorthopedic fastener and the distal opening is configured to guide thedistal tip of the anchor or other orthopedic fastener within apredetermined range of insertion trajectories. The sleeve of the anchorarm may be narrow relative to the diameter of a head and shaft of ananchor or other orthopedic fastener; the sleeve in this implementationmay be configured to guide the distal tip of the anchor or otherorthopedic fastener within a narrow predetermined range of insertiontrajectories. The sleeve of the anchor arm may be wide relative to thediameter of a head and shaft of an anchor or other orthopedic fastener;the sleeve in this implementation may be configured to guide the distaltip of the anchor or other orthopedic fastener within a widepredetermined range of insertion trajectories. The sleeve of the anchorarm may be relatively wide relative to the diameter of a head and shaftof an anchor or other orthopedic fastener; in this implementation, thesleeve may be configured to guide the distal tip of the anchor or otherorthopedic fastener within a wide predetermined range of insertiontrajectories. The sleeve may be a conical sleeve with a proximal openingthat is large relative to the distal opening; in this implementation,the conical sleeve may be configured to guide the distal tip of theanchor or other orthopedic fastener within a wide predetermined range ofinsertion trajectories.

Another implementation may be in the form of a method of fusing asacroiliac joint and providing an anchor for a spinal support system.The method may include providing a sacroiliac joint fusion and anchoringsystem that may include an implant assembly and delivery tool. Theimplant assembly may include an implant body and an anchor. The implantbody may include: an insertion element that includes an elongate bodywith a proximal insertion element end and a distal insertion elementend; and an attachment element mechanically attached to the proximalinsertion element end. The attachment element may include an anchorfitting formed within the attachment element or mechanically attached tothe attachment element. The delivery tool may include: an implant armthat includes a distal implant arm end releasably coupled to theproximal insertion element end of the implant body; and an anchor armthat includes a proximal anchor arm end coupled to the implant arm and adistal anchor arm end opposite to the proximal anchor arm end. Thedistal anchor arm end may distally end in a sleeve configured to guidethe anchor within a predetermined range of anchor insertiontrajectories.

The method may further include preparing an implant receiving space viaan extra-articular recess access region of the sacroiliac joint. Theimplant receiving space may extend from a posterior portion of thesacroiliac joint toward an anterior portion of the sacroiliac joint byremoving an amount of articular cartilage and other tissues from betweenan ilium articular surface and a sacrum articular surface defining thejoint space. The method may also include situating the insertion elementof the implant body non-transversely within the implant receiving spacesuch that the attachment fitting projects in a medial direction from ajoint line of the sacroiliac joint and the anchor fitting is situatedover a region of the sacrum just lateral to the lateral edge of the S1foramen and just superior to the superior edge of the S1 foramen. Themethod may also include inserting a driving tool through a lumen of thesleeve of the anchor arm such that a distal end of the driving tool isengaged with a proximal end of the anchor. The method may furtherinclude operating the driving tool to insert the anchor on a S2AItrajectory. In the S2AI trajectory the distal end of the anchor may passthrough the anchor fitting, enters the sacrum near a first sacralforamen in a medial to lateral direction and further enters the ilium.The method may additionally include detaching the distal end of thedelivery tool from the implant body.

The method in this implementation may also include inserting one or moreadditional fasteners through additional bores formed within theattachment member or insertion member. The one or more additionalfasteners may be chosen from one or more of: a) a first additionalfastener inserted through the ilium in a lateral to medial directionsuch that a distal tip of the first additional fastener is situatedwithin a blind bore formed within a lateral face of the insertionelement; b) a second additional fastener inserted through the ilium in alateral to medial direction such that a distal tip of the secondadditional fastener is driven through an open bore formed transverselythrough the insertion element and into the sacrum adjacent to a medialface of the insertion element; c) a third additional fastener insertedthrough the sacrum in a medial to lateral direction such that a distaltip of the third additional fastener is situated within a blind boreformed within a medial face of the insertion element; d) a fourthadditional fastener inserted through the sacrum in a medial to lateraldirection such that a distal tip of the fourth additional fastener issituated within an open bore formed transversely through the insertionelement and into the ilium adjacent to a medial face of the insertionelement; and e) a fifth additional fastener inserted through anadditional open bore formed through the attachment element in a fifthfastener direction chosen from any one of: a lateral to medial directioninto the sacrum, a medial to lateral direction into the sacrum, a medialto lateral direction into the sacrum and ilium, a cranial direction intothe sacrum, and a caudal direction into the sacrum.

The implant assembly used in this implementation of the method mayfurther include an attachment fitting attached to the attachmentelement. In this implementation, the method may further includeattaching a support element of a spinal support system to the attachmentfitting.

The anchor used in this implementation of the method may be a S2 alariliac bone screw.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present disclosure.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures illustrate various aspects of the invention.

FIG. 1 is an isometric view of a first embodiment of a system foranchoring one or more elements of a spinal stabilization system.

FIG. 2 is an isometric view of the first embodiment of the system withthe implant assembly separated from the delivery tool.

FIG. 3 is a posterior view of a first embodiment of an implant assemblyimplanted within a sacroiliac joint; a rod element of a spinalstabilization system is attached to an attachment element of the implantassembly.

FIG. 4 is a side isometric view of the implant assembly of the firstembodiment attached to the rod element from the spinal stabilizationsystem.

FIG. 5A is a side isometric of an implant body of the implant assemblyin the first embodiment.

FIG. 5B is a side isometric of an implant body of the implant assemblyin an alternative to the first embodiment.

FIG. 6A is a normal cross-sectional view of an insertion body of thefirst embodiment taken at section A-A of FIG. 5A. FIGS. 6B and 6C arenormal cross-sectional views of alternative embodiments that includeinsertion elements with curved contours.

FIG. 7A is a medial side view of the implant body of the firstembodiment.

FIGS. 7B and 7C are medial side views of implant bodies in alternativeembodiments with proximally projecting extensions of the attachmentelements. FIG. 7D and FIG. 7E are medial side views of additionalalternative embodiments that include proximally bent sections of theattachment elements. FIG. 7F is a medial side view of the implant bodyof an alternative to the first embodiment employing a distal opening.FIG. 7G is a medial side view of the implant body of an alternative tothe first embodiment employing a distal opening and a curved feature.FIG. 7H is a medial side view of the implant body of an alternative tothe first embodiment employing an elongate distal bore and a curvedfeature.

FIG. 8A is a caudal side view of the implant body of the firstembodiment. FIG. 8B is a caudal side view of an implant body with aproximally projecting extension of the insertion element similar to thealternative embodiments illustrated in FIGS. 7B-7C. FIG. 8C is a caudalside view of an implant body with a proximal/lateral projectingextension of the insertion element. FIG. 8D is a caudal side view of animplant body with a surface feature projecting distally from anattachment element. FIGS. 8E-8H are alternative embodiments that includechamfering, filleting, and ribbing along the interior corner of theimplant body; the interior corner is an enlargement of region B withinFIG. 8A.

FIG. 9 is an isometric view of a second embodiment of the implant body;and, further includes a tool engagement peg situated on an edge of theattachment element in an embodiment.

FIG. 10A is a top view of the first embodiment of the implant body. FIG.10B is a top view of the first embodiment of the implant body attachedto a delivery device. FIG. 10C is a top view of an alternativeembodiment that includes additional locations of the bore. FIG. 10D is atop view of an additional alternative embodiment that includes aprojection projecting from a proximal end of the insertion elementcoupled to a rod element of a spinal stabilization system. FIGS. 10E-10Hare cross-sectional views of the projection taken at section C-C of FIG.10D. FIGS. 101-10J are top views of attachment elements of implantbodies in other embodiments that include alternative planform profilesof the attachment elements. FIG. 10K and FIG. 10L are cross-sectionaldiagrams of the connector illustrated in FIG. 10D taken at section G-Gof FIG. 10D in two embodiments.

FIG. 11A is a lateral side view of the implant body of the firstembodiment. FIG. 11B is a side view of the implant body with a distallyprojecting extension of the attachment element and an anchor inserted ina lateral-medial trajectory: i) through the ilium (not shown), ii)through a bore in the distally projecting extension and across thesacroiliac joint (not shown), iii) into sacrum (not shown), and iv)toward the sacral promontory (not shown).

FIG. 12A is a top isometric of a third embodiment of the implant body.FIGS. 12B and 12C are normal cross-sectional view of an anchor supportelement of the implant body taken at section D-D of FIG. 12A. FIGS.12D-12F are various views of a portion of a pivoting anchor supportelement in an additional embodiment. FIGS. 12G-12H are isometric viewsof a portion of anchor support elements that include energy-absorbingelements in alternative embodiments.

FIG. 13A is a cranial side view of a fourth embodiment of the implantbody. FIG. 13B and FIG. 13C are cranial side and top views,respectively, of an implant system that includes an anchor, a rotatableinsertion element, and an indicator indicating an alignment of a bore ofthe rotatable insertion element with a bore of the attachment element.

FIG. 14 is a general side view of a section of the attachment elementaccording to certain embodiments showing the anchor inserted through theanchor fitting at various anchor insertion angles.

FIG. 15A is a top view of the implant body in the third embodiment withthe anchor inserted in a distal direction. FIG. 15B is a top view of theimplant body in the third embodiment with the anchor inserted in amedial direction. FIG. 15C is a top view of the implant body in thethird embodiment with the anchor inserted in a lateral direction.

FIG. 16A is a cross-sectional view of a vertical bore with a constantcross-sectional diameter. FIG. 16B is a cross-sectional view of anangled bore with a constant cross-sectional diameter. FIG. 16C is across-sectional view of a vertical bore with a hemisphericalcross-sectional segment. FIG. 16D is a cross-sectional view of avertical bore with a conical cross-sectional segment. FIG. 16E is across-sectional view of a vertical bore with a “compression plate”cross-sectional contour. FIGS. 16F-16G are cross-sectional views ofadditional bore cross-sectional contours.

FIG. 17 is front view of an anchor fitting with an anchor retentionfeature in one embodiment.

FIG. 18 is a side view of a polyaxial screw in one embodiment.

FIG. 19 is a side view of an attachment fitting in one embodiment.

FIG. 20 is a side view of the attachment fitting attached to the rod ofa spinal stabilization system and fixed in place on the implant body.

FIG. 21 is an isometric view of a slideable socket in one embodiment.

FIG. 22 is a cross-sectional isometric view of the slideable socket inthe one embodiment.

FIG. 23 is a side cross-sectional isometric view of the slideable socketin the one embodiment attached to the rod of a spinal stabilizationsystem and fixed in place on the implant body.

FIG. 24 is a top view of the implant body in a fourth embodiment with aslideable attachment socket situated on a pivoting guide rail.

FIG. 25 is a top view of the implant body in a fifth embodiment with afirst and second slideable attachment sockets situated on an elongatedpivoting guide rail.

FIG. 26 is a bottom isometric view of an insertion plate of an implantbody with a first embodiment of anti-migration surface features includedon the exposed surfaces.

FIG. 27 is a front isometric view of an insertion plate of an implantbody with a second embodiment of anti-migration surface featuresincluded on the exposed surfaces of the insertion plate.

FIG. 28A is a front isometric view of an insertion plate of an implantbody with a third embodiment of anti-migration surface features includedin the form of notches distributed along longitudinally extending freeedges or ends of the fins. FIG. 28B is a rotated side view of theinsertion plate illustrated in FIG. 28A.

FIG. 29A is a front isometric view of an insertion plate of an implantbody with a fourth embodiment of anti-migration surface featuresincluded in the form of are flared longitudinally extending free edgesor ends of the fins. FIG. 29B is a transverse cross-sectional view ofthe insertion plate illustrated in FIG. 29A.

FIG. 30 is a side view of an anchor in a first embodiment.

FIG. 31 is a side view of an anchor in a second embodiment.

FIG. 32 is a top view of the anchor in the first embodiment.

FIG. 33A is a side view of a Steffee-type anchor in one embodiment. FIG.33B is a side view of a Steffee-type anchor in a second embodimentincluding a nut and a driver segment configured with rounded/curvedopposing faces to allow different angles between an anchor and plate.

FIG. 34A is a medial side view of the implant body of the firstembodiment secured using the Steffee-type anchor illustrated in FIG.33A. FIG. 34B is a medial side view of the implant body of the firstembodiment secured using the Steffee-type anchor illustrated in FIG. 33Bin which the longitudinal axis of the anchor is secured in anon-perpendicular alignment relative to the surface of the attachmentelement. FIG. 34C is a medial side view of the implant body of the firstembodiment secured using a polyaxial screw similar to the oneillustrated in FIG. 18.

FIG. 35 is an exploded view of the delivery tool in the firstembodiment.

FIG. 36 is a close-up perspective view of the distal end of the deliverytool in the first embodiment.

FIG. 37 is a close-up perspective view of the distal end of the deliverytool in the first embodiment with an attached implant body.

FIG. 38 is a top view of an anchor arm attached to an implant arm of thedelivery tool in the first embodiment.

FIGS. 39A and 39B are perspective views of a delivery tool in a secondembodiment attached to an implant body.

FIG. 40 is a perspective view of the implant arm of the delivery tool inthe second embodiment.

FIG. 41 is a longitudinal cross-sectional view of the implant arm of thedelivery tool in the second embodiment.

FIG. 42 is a side view of an implant retaining arm.

FIG. 43A is a side cross-sectional/cutaway view of the delivery tool ina second embodiment attached to an implant body with an anchor andpolyaxial screw installed. FIG. 43B is an isometric view of anotherembodiment of an implant assembly including an implant body with apolyaxial or monoaxial attachment fitting situated on the attachmentelement wherein the attachment fitting is located between a first andsecond attachment element bore.

FIG. 44A is a right lateral side view of a hip region of a patient lyingprone, wherein the soft tissue surrounding the skeletal structure of thepatient is shown in dashed lines.

FIG. 44B is an enlarged view of the hip region of FIG. 44A.

FIG. 45A is a lateral-posterior view of the hip region of the patient ofFIG. 44A, wherein the patient is lying prone and the soft tissuesurrounding the skeletal structure of the patient is shown in dashedlines.

FIG. 45B is an enlarged view of the hip region of FIG. 45A.

FIG. 46A is a posterior view of the hip region of the patient of FIG.45A, wherein the patient is lying prone and the soft tissue surroundingthe skeletal structure of the patient is shown in dashed lines.

FIG. 46B is an enlarged view of the hip region of FIG. 46A.

FIGS. 47A-47Q are each illustrations of a step in the methodology in oneembodiment and are each illustrated as a transverse cross section takenalong a plane extending medial-lateral and anterior posterior alongsection 99-99 in FIG. 46B.

FIG. 48A is a posterior-lateral view of the hip region of the patient,illustrating the placement of a cannula alignment jig. FIGS. 48B-48C areadditional isometric views of the cannula alignment jig.

FIG. 49A is a posterior-lateral view of the hip region of the patient,illustrating the placement of a drill jig. FIG. 49B is an isometric viewof the drill jig illustrated in FIG. 49A. FIG. 49C-49E are side, top,and front views, respectively, of a cannula in an embodiment. FIG. 49Fis a posterior-lateral view of the hip region of the patient,illustrating the placement of the cannula illustrated in FIGS. 49C-49Efor use during a sacroiliac joint procedure via a posterior inferioraccess region. FIG. 49G is a posterior-lateral view of the hip region ofthe patient illustrating the placement of the cannula of FIGS. 49C-49E.FIG. 49H is a posterior-lateral view of the hip region of the patient,illustrating the placement of the cannula of FIGS. 49C-49E, in which aposterior inferior access region of a sacroiliac joint articular regionon a sacroiliac joint line is visible. FIG. 49I is a generallyposterior-inferior view of the hip region of the patient, illustratingthe placement of the cannula of FIGS. 49C-49E. FIG. 49J is a generallyposterior-inferior view of the hip region of the patient, illustratingthe placement of the cannula of FIGS. 49C-49E. FIG. 49K is aposterior-lateral view of the hip region of the patient, illustratingthe placement of the cannula of FIGS. 49C-49E, wherein a posteriorinferior access region of a sacroiliac joint articular region on asacroiliac joint line is visible.

FIG. 50A is a lateral view of the hip region of the patient,illustrating the implant implanted in the caudal region of thesacroiliac join space.

FIG. 50B is an anterior view of the hip region of the patient,illustrating the implant implanted in the caudal region of thesacroiliac join space.

FIG. 50C is an enlarged view of the implant taken along the plane of thesacroiliac joint.

FIG. 50D is a transverse cross section of the implant and joint planetaken along section line 1020-1020 of FIG. 50C.

FIG. 51A is a lateral-posterior view of the hip region of the patientillustrating the position and alignment of a delivery tool being used todeliver the implant to the sacroiliac joint space.

FIG. 51B is an enlarged view of the delivery tool and implant assemblywithin the hip region illustrated in FIG. 51A.

FIG. 52 is a lateral view of the hip region of the patient illustratingthe position and alignment of a delivery tool being used to deliver theimplant assembly to the sacroiliac joint space.

FIG. 53 is the lateral view of FIG. 52, with the implant assembly fullyinserted into the prepared space in the sacroiliac joint.

FIG. 54 is the lateral view of FIG. 53 with the ilium removed to exposethe sacroiliac joint space boundary defined along the sacrum and theimplant positioned for implantation within the joint space.

FIG. 55 is a posterior-inferior view of the hip region of the patientillustrating the position and alignment of a delivery tool being used todeliver the implant to the sacroiliac joint space; the soft tissuessurrounding the skeletal hip bones are represented as dashed lines.

FIG. 56 is a posterior view of the implantation area and fully-insertedimplant assembly.

FIG. 57 is a lateral-inferior-posterior view of the implant assembly anddelivery tool positioned within a patient's hip skeletal structure.

FIG. 58 is an inferior-posterior view of the implant assembly anddelivery tool positioned within a patient's hip skeletal structure.

FIG. 59 is a lateral side view of a hip region of a patient lying pronewith the ilium removed showing the implant body positioned forimplantation within the extra-articular space.

FIGS. 60A-60P illustrate successive steps in a second methodologyembodiment; each step is illustrated within the transverse cross sectiontaken along a plane extending medial-lateral and anterior posterioralong section line 101-101 in FIG. 46B.

FIG. 61 is a posterior view of the implant assembly fully insertedwithin the implantation area.

FIGS. 62-91 are various views of the sacroiliac joint and associatedskeletal structures of a patient illustrating the position andorientation of the delivery tool and/or implant assembly in variousembodiments during implantation of the implant assembly within theextra-articular space of the sacroiliac joint using various embodimentsof a method.

FIG. 92 is a side isometric view of a threaded cylinder insertionelement in an embodiment.

FIG. 93 is a cross-sectional view of the threaded cylinder insertionelement in the embodiment.

FIG. 94A is a side isometric view of the threaded cylinder insertionelement reversibly coupled to a delivery tool in an embodiment. FIG. 94Bis an exploded side isometric view of the threaded cylinder insertionelement illustrating the reversible coupling of the threaded cylinderinsertion element to a delivery tool in an embodiment.

FIG. 95 is a cross-sectional view of the threaded cylinder insertionelement reversibly coupled to the delivery tool.

FIG. 96 is an isometric view of an implant assembly that includes athreaded conical insertion element reversibly coupled to a driver toolin an embodiment, wherein the insertion element is helically threadedand driven with rotation forces.

FIG. 97A is an exploded isometric view of an implant assembly withrecessed elements reversibly coupled to a hemostat-type delivery tool inan embodiment. FIG. 97B is a close-up exploded isometric view of theimplant assembly with recessed elements reversibly coupled to thehemostat-type delivery tool. FIG. 97C is a close-up isometric view ofthe implant assembly with recessed elements mounted to the hemostat-typedelivery tool.

FIG. 98 is a side view of an implant system in which the implant bodyconsists of multiple implant bodies or pieces (e.g., 2 or 3 or morepieces) in one embodiment thereby permitting motion at a sacroiliacjoint.

FIGS. 99-119 are various views of the sacroiliac joint and associatedskeletal structures of a patient illustrating the position andorientation of an implant assembly with a multiaxial attachment fittingin one embodiment after completion of implantation.

FIGS. 120-126 are various views of the implant body and anchorsillustrated in FIGS. 99-119.

FIG. 127 and FIG. 128 are a top and isometric view, respectively of theimplant body illustrated in FIGS. 99-126.

FIG. 129 and FIG. 130 are cross-sectional views taken at section E-E ofFIG. 128, viewed from different angles relative to the section plane.

FIG. 131 is an illustration of the various mechanical elements includedin the implant assembly illustrated in FIGS. 99-130.

FIG. 132 and FIG. 133 are a lateral-posterior view and acranial-posterior view, respectively, of the sacroiliac joint andassociated skeletal structures of a patient illustrating the positionand orientation of an implant assembly with a multiaxial attachmentfitting in a second embodiment after completion of implantation.

FIGS. 134-139 are various views of the implant assembly illustrated inFIG. 132 and FIG. 133 with the skeletal structures of the patientremoved to enhance visualization.

FIGS. 140-145 are close-up views of the multiaxial attachment fittingfrom the implant assembly illustrated in FIGS. 132-139 attached to a rodfrom a spinal stabilization device.

FIG. 146 and FIG. 147 are close-up cross-sectional views of themultiaxial attachment fitting from the implant assembly illustrated inFIGS. 132-145 to illustrate the spatial arrangement of the elements ofthe multiaxial attachment fitting fastened to the rod element of thespinal stabilization device.

FIG. 148 is an exploded isometric view of the multiaxial attachmentfitting from the implant assembly illustrated in FIGS. 132-147 toillustrate the assembly of the elements of the multiaxial attachmentfitting used to fasten the rod element of the spinal stabilizationdevice.

FIG. 149 and FIG. 150 are isometric views of the elements of themultiaxial attachment fitting illustrated in FIGS. 132-148 fromdifferent elevations.

FIG. 151 and FIG. 152 are side cross-sectional views of the elements ofthe multiaxial attachment fitting and the assembled multiaxialattachment fitting, respectively, in the embodiment previouslyillustrated in FIGS. 132-150.

FIGS. 153-156 are various isometric views of an implant assembly with amonoaxial attachment fitting in a third embodiment.

FIG. 157 is a cross-sectional view on the implant assembly illustratedin FIGS. 153-156 taken at section F-F of FIG. 156.

FIGS. 158-173 are various views of the sacroiliac joint and associatedskeletal structures of a patient illustrating the position andorientation of an implant assembly with a multiaxial attachment fittingin the embodiment previously illustrated in FIGS. 132-152 aftercompletion of implantation.

FIG. 174 is an isometric view of an insertion assembly with a multiaxialattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 175 is a front view of an insertion assembly with a multiaxialattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 176 is a side view of an insertion assembly with a multiaxialattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 177 is a top view of an insertion assembly with a multiaxialattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 178 is a top view of an insertion assembly with a hook-likeattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 179 is an isometric view of an insertion assembly with a hook-likeattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 180 is a side view of an insertion assembly with a hook-likeattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 181 is a front view of an insertion assembly with a hook-likeattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 182 is a top view of an insertion assembly with a hook-likeattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 183 is an isometric view of an insertion assembly with a pivotingclamp attachment fitting and one anchor directed laterally downwardthrough the insertion element.

FIG. 184 is a front view of an insertion assembly with a pivoting clampattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 185 is a top view of an insertion assembly with a pivoting clampattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 186 is a side view of an insertion assembly with a pivoting clampattachment fitting and one anchor directed laterally downward throughthe insertion element.

FIG. 187 is an isometric view of an insertion assembly with a verticallysliding clamp attachment fitting and one anchor directed laterallydownward through the insertion element.

FIG. 188 is a front view of an insertion assembly with a verticallysliding clamp attachment fitting and one anchor directed laterallydownward through the insertion element.

FIG. 189 is a top view of an insertion assembly with a verticallysliding clamp attachment fitting and one anchor directed laterallydownward through the insertion element.

FIG. 190 is a side view of an insertion assembly with a verticallysliding clamp attachment fitting and one anchor directed laterallydownward through the insertion element.

FIG. 191 is a close-up side view of the hook-like attachment fitting ofFIGS. 178-182 in an embodiment.

FIGS. 192-212 are various views of the insertion assembly with thehook-like attachment fitting of FIGS. 178-182 and FIG. 191.

FIGS. 213-244 are various views of the insertion assembly with thepivoting clamp attachment fitting of FIGS. 183-186.

FIGS. 245-257, 258A, and 258B are various views of the insertionassembly with the vertically sliding clamp attachment fitting of FIGS.187-190.

FIG. 259 is an isometric view of a bottom side of a surgical preparationtool assembly including a trial tool assembly and a cutting tool.

FIG. 260 is an isometric view of a top side of the surgical preparationtool assembly of FIG. 259.

FIGS. 261A-261D are steps in the methodology of preparing a sacroiliacjoint for fusion utilizing the joint preparation tool assembliesdescribed in FIGS. 259 and 260.

FIG. 262A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 262B is a top view of the sacroiliac joint implant of FIG. 262A.

FIG. 262C is a bottom view of the sacroiliac joint implant of FIG. 262Aopposite the top view of FIG. 262B.

FIG. 262D is a side view of the sacroiliac joint implant of FIG. 262A.

FIG. 262E is a side view of the sacroiliac joint implant of FIG. 262Aopposite the side view of FIG. 262D.

FIG. 262F is a back view of the sacroiliac joint implant of FIG. 262A.

FIG. 262G is a front view of the sacroiliac joint implant of FIG. 262Aopposite the back view of FIG. 262F.

FIG. 263A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 263B is a front isometric view of the sacroiliac joint implant ofFIG. 263A.

FIG. 263C is a back isometric view of the sacroiliac joint implant ofFIG. 263A.

FIG. 263D is a back-side view of the sacroiliac joint implant of FIG.263A.

FIG. 263E is a side view of the sacroiliac joint implant of FIG. 263A.

FIG. 263F is a side view of the sacroiliac joint implant of FIG. 263Aopposite the side view of FIG. 263E.

FIG. 263G is a top view of the sacroiliac joint implant of FIG. 263A.

FIG. 263H is a bottom view of the sacroiliac joint implant of FIG. 263Aopposite the top view of FIG. 263G.

FIG. 263I is a front view of the sacroiliac joint implant of FIG. 263A.

FIG. 263J is a back view of the sacroiliac joint implant of FIG. 263Aopposite the front view of FIG. 263I.

FIG. 264A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 264B is a front isometric view of the sacroiliac joint implant ofFIG. 264A.

FIG. 264C is a back isometric view of the sacroiliac joint implant ofFIG. 264A.

FIG. 264D is a back-side view of the sacroiliac joint implant of FIG.264A.

FIG. 264E is a side view of the sacroiliac joint implant of FIG. 264A.

FIG. 264F is a side view of the sacroiliac joint implant of FIG. 264Aopposite the side view of FIG. 264E.

FIG. 264G is a top view of the sacroiliac joint implant of FIG. 264A.

FIG. 264H is a bottom view of the sacroiliac joint implant of FIG. 264Aopposite the top view of FIG. 264G.

FIG. 264I is a front view of the sacroiliac joint implant of FIG. 264A.

FIG. 264J is a back view of the sacroiliac joint implant of FIG. 264Aopposite the front view of FIG. 264I.

FIG. 265A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 265B is a front isometric view of the sacroiliac joint implant ofFIG. 265A.

FIG. 265C is a back isometric view of the sacroiliac joint implant ofFIG. 265A.

FIG. 265D is a back-side view of the sacroiliac joint implant of FIG.265A.

FIG. 265E is a side view of the sacroiliac joint implant of FIG. 265A.

FIG. 265F is a side view of the sacroiliac joint implant of FIG. 265Aopposite the side view of FIG. 265E.

FIG. 265G is a top view of the sacroiliac joint implant of FIG. 265A.

FIG. 265H is a bottom view of the sacroiliac joint implant of FIG. 265Aopposite the top view of FIG. 265G.

FIG. 265I is a front view of the sacroiliac joint implant of FIG. 265A.

FIG. 265J is a back view of the sacroiliac joint implant of FIG. 265Aopposite the front view of FIG. 265I.

FIG. 266A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 266B is a front isometric view of the sacroiliac joint implant ofFIG. 266A.

FIG. 266C is a back isometric view of the sacroiliac joint implant ofFIG. 266A.

FIG. 266D is a back-side view of the sacroiliac joint implant of FIG.266A.

FIG. 266E is a side view of the sacroiliac joint implant of FIG. 266A.

FIG. 266F is a side view of the sacroiliac joint implant of FIG. 266Aopposite the side view of FIG. 266E.

FIG. 266G is a top view of the sacroiliac joint implant of FIG. 266A.

FIG. 266H is a bottom view of the sacroiliac joint implant of FIG. 266Aopposite the top view of FIG. 266G.

FIG. 266I is a front view of the sacroiliac joint implant of FIG. 266A.

FIG. 266J is a back view of the sacroiliac joint implant of FIG. 266Aopposite the front view of FIG. 266I.

FIG. 267A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 267B is a front isometric view of the sacroiliac joint implant ofFIG. 267A.

FIG. 267C is a back isometric view of the sacroiliac joint implant ofFIG. 267A.

FIG. 267D is a back-side view of the sacroiliac joint implant of FIG.267A.

FIG. 267E is a side view of the sacroiliac joint implant of FIG. 267A.

FIG. 267F is a side view of the sacroiliac joint implant of FIG. 267Aopposite the side view of FIG. 267E.

FIG. 267G is a top view of the sacroiliac joint implant of FIG. 267A.

FIG. 267H is a bottom view of the sacroiliac joint implant of FIG. 267Aopposite the top view of FIG. 267G.

FIG. 267I is a front view of the sacroiliac joint implant of FIG. 267A.

FIG. 267J is a back view of the sacroiliac joint implant of FIG. 267Aopposite the front view of FIG. 267I.

FIG. 268A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 268B is a front isometric view of the sacroiliac joint implant ofFIG. 268A.

FIG. 268C is a back isometric view of the sacroiliac joint implant ofFIG. 268A.

FIG. 268D is a back-side view of the sacroiliac joint implant of FIG.268A.

FIG. 268E is a side view of the sacroiliac joint implant of FIG. 268A.

FIG. 268F is a side view of the sacroiliac joint implant of FIG. 268Aopposite the side view of FIG. 268E.

FIG. 268G is a top view of the sacroiliac joint implant of FIG. 268A.

FIG. 268H is a bottom view of the sacroiliac joint implant of FIG. 268Aopposite the top view of FIG. 268G.

FIG. 268I is a front view of the sacroiliac joint implant of FIG. 268A.

FIG. 268J is a back view of the sacroiliac joint implant of FIG. 268Aopposite the front view of FIG. 268I.

FIG. 269A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 269B is a front isometric view of the sacroiliac joint implant ofFIG. 269A.

FIG. 269C is a back isometric view of the sacroiliac joint implant ofFIG. 269A.

FIG. 269D is a back-side view of the sacroiliac joint implant of FIG.269A.

FIG. 269E is a side view of the sacroiliac joint implant of FIG. 269A.

FIG. 269F is a side view of the sacroiliac joint implant of FIG. 269Aopposite the side view of FIG. 269E.

FIG. 269G is a top view of the sacroiliac joint implant of FIG. 269A.

FIG. 269H is a bottom view of the sacroiliac joint implant of FIG. 269Aopposite the top view of FIG. 269G.

FIG. 269I is a front view of the sacroiliac joint implant of FIG. 269A.

FIG. 269J is a back view of the sacroiliac joint implant of FIG. 269Aopposite the front view of FIG. 269I.

FIG. 270A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 270B is a front isometric view of the sacroiliac joint implant ofFIG. 270A.

FIG. 270C is a back isometric view of the sacroiliac joint implant ofFIG. 270A.

FIG. 270D is a back-side view of the sacroiliac joint implant of FIG.270A.

FIG. 270E is a side view of the sacroiliac joint implant of FIG. 270A.

FIG. 270F is a side view of the sacroiliac joint implant of FIG. 270Aopposite the side view of FIG. 270E.

FIG. 270G is a top view of the sacroiliac joint implant of FIG. 270A.

FIG. 270H is a bottom view of the sacroiliac joint implant of FIG. 270Aopposite the top view of FIG. 270G.

FIG. 270I is a front view of the sacroiliac joint implant of FIG. 270A.

FIG. 270J is a back view of the sacroiliac joint implant of FIG. 270Aopposite the front view of FIG. 270I.

FIG. 271A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 271B is a front isometric view of the sacroiliac joint implant ofFIG. 271A.

FIG. 271C is a back isometric view of the sacroiliac joint implant ofFIG. 271A.

FIG. 271D is a back-side view of the sacroiliac joint implant of FIG.271A.

FIG. 271E is a side view of the sacroiliac joint implant of FIG. 271A.

FIG. 271F is a side view of the sacroiliac joint implant of FIG. 271Aopposite the side view of FIG. 271E.

FIG. 271G is a top view of the sacroiliac joint implant of FIG. 271A.

FIG. 271H is a bottom view of the sacroiliac joint implant of FIG. 271Aopposite the top view of FIG. 271G.

FIG. 271I is a front view of the sacroiliac joint implant of FIG. 271A.

FIG. 271J is a back view of the sacroiliac joint implant of FIG. 271Aopposite the front view of FIG. 271I.

FIG. 272A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 272B is a front isometric view of the sacroiliac joint implant ofFIG. 272A.

FIG. 272C is a back isometric view of the sacroiliac joint implant ofFIG. 272A.

FIG. 272D is a back-side view of the sacroiliac joint implant of FIG.272A.

FIG. 272E is a side view of the sacroiliac joint implant of FIG. 272A.

FIG. 272F is a side view of the sacroiliac joint implant of FIG. 272Aopposite the side view of FIG. 272E.

FIG. 272G is a top view of the sacroiliac joint implant of FIG. 272A.

FIG. 272H is a bottom view of the sacroiliac joint implant of FIG. 272Aopposite the top view of FIG. 272G.

FIG. 272I is a front view of the sacroiliac joint implant of FIG. 272A.

FIG. 272J is a back view of the sacroiliac joint implant of FIG. 272Aopposite the front view of FIG. 272I.

FIG. 273A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 273B is a front isometric view of the sacroiliac joint implant ofFIG. 273A.

FIG. 273C is a back isometric view of the sacroiliac joint implant ofFIG. 273A.

FIG. 273D is a back-side view of the sacroiliac joint implant of FIG.273A.

FIG. 273E is a side view of the sacroiliac joint implant of FIG. 273A.

FIG. 273F is a side view of the sacroiliac joint implant of FIG. 273Aopposite the side view of FIG. 273E.

FIG. 273G is a top view of the sacroiliac joint implant of FIG. 273A.

FIG. 273H is a bottom view of the sacroiliac joint implant of FIG. 273Aopposite the top view of FIG. 273G.

FIG. 273I is a front view of the sacroiliac joint implant of FIG. 273A.

FIG. 273J is a back view of the sacroiliac joint implant of FIG. 273Aopposite the front view of FIG. 273I.

FIG. 274A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 274B is a front isometric view of the sacroiliac joint implant ofFIG. 274A.

FIG. 274C is a back isometric view of the sacroiliac joint implant ofFIG. 274A.

FIG. 274D is a back-side view of the sacroiliac joint implant of FIG.274A.

FIG. 274E is a side view of the sacroiliac joint implant of FIG. 274A.

FIG. 274F is a side view of the sacroiliac joint implant of FIG. 274Aopposite the side view of FIG. 274E.

FIG. 274G is a top view of the sacroiliac joint implant of FIG. 274A.

FIG. 274H is a bottom view of the sacroiliac joint implant of FIG. 274Aopposite the top view of FIG. 274G.

FIG. 274I is a front view of the sacroiliac joint implant of FIG. 274A.

FIG. 274J is a back view of the sacroiliac joint implant of FIG. 274Aopposite the front view of FIG. 274I.

FIG. 275A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 275B is a front isometric view of the sacroiliac joint implant ofFIG. 275A.

FIG. 275C is a back isometric view of the sacroiliac joint implant ofFIG. 275A.

FIG. 275D is a back-side view of the sacroiliac joint implant of FIG.275A.

FIG. 275E is a side view of the sacroiliac joint implant of FIG. 275A.

FIG. 275F is a side view of the sacroiliac joint implant of FIG. 275Aopposite the side view of FIG. 275E.

FIG. 275G is a top view of the sacroiliac joint implant of FIG. 275A.

FIG. 275H is a bottom view of the sacroiliac joint implant of FIG. 275Aopposite the top view of FIG. 275G.

FIG. 275I is a front view of the sacroiliac joint implant of FIG. 275A.

FIG. 275J is a back view of the sacroiliac joint implant of FIG. 275Aopposite the front view of FIG. 275I.

FIG. 276A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 276B is a front isometric view of the sacroiliac joint implant ofFIG. 276A.

FIG. 276C is a back isometric view of the sacroiliac joint implant ofFIG. 276A.

FIG. 276D is a back-side view of the sacroiliac joint implant of FIG.276A.

FIG. 276E is a side view of the sacroiliac joint implant of FIG. 276A.

FIG. 276F is a side view of the sacroiliac joint implant of FIG. 276Aopposite the side view of FIG. 276E.

FIG. 276G is a top view of the sacroiliac joint implant of FIG. 276A.

FIG. 276H is a bottom view of the sacroiliac joint implant of FIG. 276Aopposite the top view of FIG. 276G.

FIG. 276I is a front view of the sacroiliac joint implant of FIG. 276A.

FIG. 276J is a back view of the sacroiliac joint implant of FIG. 276Aopposite the front view of FIG. 276I.

FIG. 277A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 277B is a front isometric view of the sacroiliac joint implant ofFIG. 277A.

FIG. 277C is a back isometric view of the sacroiliac joint implant ofFIG. 277A.

FIG. 277D is a back-side view of the sacroiliac joint implant of FIG.277A.

FIG. 277E is a side view of the sacroiliac joint implant of FIG. 277A.

FIG. 277F is a side view of the sacroiliac joint implant of FIG. 277Aopposite the side view of FIG. 277E.

FIG. 277G is a top view of the sacroiliac joint implant of FIG. 277A.

FIG. 277H is a bottom view of the sacroiliac joint implant of FIG. 277Aopposite the top view of FIG. 277G.

FIG. 277I is a front view of the sacroiliac joint implant of FIG. 277A.

FIG. 277J is a back view of the sacroiliac joint implant of FIG. 277Aopposite the front view of FIG. 277I.

FIG. 278A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 278B is a front isometric view of the sacroiliac joint implant ofFIG. 278A.

FIG. 278C is a back isometric view of the sacroiliac joint implant ofFIG. 278A.

FIG. 278D is a back-side view of the sacroiliac joint implant of FIG.278A.

FIG. 278E is a side view of the sacroiliac joint implant of FIG. 278A.

FIG. 278F is a side view of the sacroiliac joint implant of FIG. 278Aopposite the side view of FIG. 278E.

FIG. 278G is a top view of the sacroiliac joint implant of FIG. 278A.

FIG. 278H is a bottom view of the sacroiliac joint implant of FIG. 278Aopposite the top view of FIG. 278G.

FIG. 278I is a front view of the sacroiliac joint implant of FIG. 278A.

FIG. 278J is a back view of the sacroiliac joint implant of FIG. 278Aopposite the front view of FIG. 278I.

FIG. 279A is an isometric view of a sacroiliac joint implant in aparticular embodiment.

FIG. 279B is a front isometric view of the sacroiliac joint implant ofFIG. 279A.

FIG. 279C is a back isometric view of the sacroiliac joint implant ofFIG. 279A.

FIG. 279D is a back-side view of the sacroiliac joint implant of FIG.279A.

FIG. 279E is a side view of the sacroiliac joint implant of FIG. 279A.

FIG. 279F is a side view of the sacroiliac joint implant of FIG. 279Aopposite the side view of FIG. 279E.

FIG. 279G is a top view of the sacroiliac joint implant of FIG. 279A.

FIG. 279H is a bottom view of the sacroiliac joint implant of FIG. 279Aopposite the top view of FIG. 279G.

FIG. 279I is a front view of the sacroiliac joint implant of FIG. 279A.

FIG. 279J is a back view of the sacroiliac joint implant of FIG. 279Aopposite the front view of FIG. 279I.

Corresponding reference characters and labels indicate correspondingelements among the views of the drawings. The headings used in thefigures should not be interpreted to limit the scope of the claims.

DETAILED DESCRIPTION

Implementations of the present disclosure involve an anchoring systemfor attaching one or more elements of a spinal stabilization system andconcomitantly fusing, fixating, replacing, reconstructing, stabilizingor otherwise treating a sacroiliac joint. FIG. 1 is an isometric view ofan anchoring system 10 in one embodiment. The system 10 includes adelivery tool 20 and an implant assembly 15 for delivery to a sacroiliacjoint via the delivery tool 20. The implant assembly 15, which includesan implant body 25 and anchor 30, is configured to fuse or stabilize asacroiliac joint once implanted at the joint. The implant assembly 15further includes an attachment fitting 500 configured to attach to anelement of a spinal stabilization system such as a rod 2096.

The delivery tool 20 is configured such that the anchor 30 can bequickly, accurately and reliably delivered to the implant body 25supported off of the tool distal end 35 in a sacroiliac joint. Once theimplant assembly 15 is delivered to the sacroiliac joint and secured inplace using the anchor 30, the implant assembly 15 may be detached fromthe distal end 35 of the delivery tool 20, as illustrated in FIG. 2.

FIG. 3 is a posterior view of an ilium 1005 and sacrum 1004 forming asacroiliac joint 1000. The implant assembly 15 is installed in thesacroiliac joint 1000 and secured in place by the anchor 30, whichextends from the sacrum 1004 to the ilium 1005 in this embodiment. A rod2096 from a spinal stabilization system may be attached to an attachmentfitting 500 of the implant system 15 and locked into place, therebyproviding a robust anchor for the spinal stabilization system. Inaddition to providing the robust anchor for the rod 2096, the implantassembly 15 also fuses or stabilizes the sacroiliac joint 1000 by virtueof the anchor 30, which may extend distally and laterally from thesacrum into the ilium to form the fused or stabilized joint asillustrated in FIG. 3. In some embodiments, the implant assembly 15 mayalso fuse or stabilize the sacroiliac joint 1000 by virtue of theinsertion element 650 which may be configured to fixate the preparedjoint surfaces thereby permitting bony fusion to occur through, around,near, up to or onto the implant body 25.

The embodiments of the anchoring system 15 overcome many of thelimitations of previous anchoring methods used in conjunction withprevious spinal stabilization systems. The implant body 25 is configuredto fuse or stabilize the sacroiliac joint, thereby reducing the risk ofdegradation or failure of the sacroiliac joint to which the anchoringsystem 15 is attached. In addition to the anchor 30, which bridges thesacroiliac joint and secures the ilium to the sacrum, the implant body25 of the implant assembly 15 includes an insertion element (no shown)that is situated within the sacroiliac joint in a distal orientationbetween the articular surfaces of the ilium and sacrum. The insertionelement 650 may incorporate features such as surface textures, fittings,and/or receptacles for additional fasteners that enhance the grip of theinsertion element within the sacroiliac joint. In addition, one or moreof these features may facilitate the integration of surrounding bonetissue into the peripheral margins of the implant assembly 15 duringchronic residence of the implant body 25 to further strengthen thefusion of the sacroiliac joint. This integration of bone tissue mayfurther function as a redundant fusion fixation mechanism to compensatefor any loosening of the anchor 30 or other fasteners anchoring theimplant assembly 15 in place, thereby maintaining the integrity of theimplant assembly 15 as an attachment for the spinal stabilizationsystem.

Further, as discussed in further detail herein below, the implantassembly 15 has a relatively low profile, enabling the implantationprocedure to install the implant assembly 15 using a smaller incisionsurgical procedure that entails removal of less bone and/or soft tissuesto prepare the surgical area, resulting in a lower risk ofpost-operative pain and/or other adverse events. In addition, the lowprofile of the implant assembly 15 may reduce the risk of chronic softtissue irritation relative to existing devices and methods duringlong-term use of the implant assembly 15.

Referring again to FIG. 3, the attachment fitting 500 may be designed topermit the translation and/or rotation of the attached end of the rod2096 through a wide range of motion and variety of directions, therebyfacilitating the alignment of the rod 2096 within its associated spinalstabilization system without need for excessive bending of the rod 2096.This adjustability may reduce reactive forces applied to the underlyingimplant body 25 and anchor 30 during any required bending of the rod2096 during the installation of the spinal stabilization system. Inaddition, the enhanced adjustability afforded by the design of theattachment fitting 500 may result in the reduction of smallmisalignments of the rod 2096 within the spinal stabilization system,thereby reducing the occurrence of internal forces within the spinalstabilization system; this reduction in internal forces may reduce therisk of developing pain in regions surrounding the spinal stabilizationsystem and/or degradation of joints adjacent to the afflicted joint.Furthermore, the various embodiments described herein may simplify thesurgery and reduce operating time, fluoroscopy time (ionizing radiationfrom imaging technology) and anesthesia time thereby making the surgicalprocedure safer and more efficacious than conventional methods andsystems. Further, the various embodiments described herein may furtherallow the treatment of patients who might otherwise not be able toundergo conventional surgery to treat a musculoskeletal pathology.

The implant assembly 15 may be further configured to dissipate forcesarising from an attached spinal construct over a greater surface area ofthe pelvis while acting as a shock absorber by a semi constrainedcommunication between the components of a spinal construct and implantassembly 15.

Detailed descriptions of various embodiments of the anchoring system 10including the implant assembly 15, delivery tool 20, as well as methodsof using the system 10 to provide an attachment for a spinalstabilization system are provided herein below.

I. Implant Assembly

To begin a detailed discussion of components of various embodiments ofthe implant assembly 15, reference is made to FIG. 4, which is a sideisometric view of the implant assembly 15 with attached rod 2096 in oneaspect. As shown in FIG. 4, the implant assembly 15 includes an implantbody 25, an anchor 30, and an attachment fitting 500. The anchor 30 isconfigured to be received in a bore 40 defined through the implant body25. The bore 40 extends through the implant body 25 and is sized suchthat the anchor element 30 can extend through the implant body 25 asillustrated in FIG. 4 and into the underlying bone tissue (not shown).

The attachment fitting 500 in this embodiment is configured to bereceived within a guide 505 formed within the implant body 25. Ingeneral, the guide 505 accommodates limited translations and/orrotations of the attachment fitting 500, and further provides theability to lock the attachment fitting 500 in a fixed position relativeto the implant body 25 when the rod 2096 is locked into place within theattachment fitting 500. The guide 505 may be a slot as illustrated inFIG. 4, or any of a variety of other embodiments discussed in detailherein below.

a. Implant Body

To begin a detailed discussion of the implant body 25, reference is madeto FIG. 5A, which is a side isometric view of an implant body 25 in oneembodiment. In general, the implant body 25 includes an insertionelement 650 and an attachment element 652. The insertion element 650 isconfigured to be inserted into the joint space of a sacroiliac joint ina direction that is essentially parallel to, or sufficiently engagedwith, the articulating surfaces of the sacrum and ilium to implement therobust anchoring of the implant body 25.

Additional features of the insertion element 650 such as open and/orblind bores may interact mechanically with the anchor 30 (not shown) andoptional additional fasteners to enhance the anchoring of the implantbody 25. Other additional features of the insertion element such as fins50 or other projections such as surface textures (not shown) may enhancethe grip of the insertion element 650 within the joint space of thesacroiliac joint; these other additional features may further enhancethe integration of bone tissue within the joint space into the surfaceof the insertion element 650, thereby strengthening the mechanicalfusion and immobilization of the sacroiliac joint.

The implant body 25 also typically includes an attachment element 652configured to mechanically interact with the anchor 30 to secure theimplant body 25 to the sacroiliac joint. In addition, the attachmentelement 652 typically includes a guide 505, such as the slot 505illustrated in FIG. 4. In general, the guide 505 is configured toreceive the attachment fitting 500 (not shown) and allow limitedtranslation and rotation of the attachment fitting 500 to allow forminor adjustments of the position and/or orientation of the rod 2096(not shown) within the spinal stabilization system prior to locking theattachment fitting 500 to the guide 505 of the implant body 25.

In various embodiments described herein below, the implant body 25 mayhave a variety of external shapes and cross-sectional profiles dependingupon the desired properties and uses of the implant body 25. Forexample, different shapes, sizes, and/or cross-sectional profiles of theimplant body 25 may be selected to accommodate various patientmorphologies, shapes and types of anchors and orthopedic fasteners,and/or any other relevant criteria.

In various embodiments, the implant body 25 may be machined, molded,formed, or otherwise manufactured from stainless steel, titanium,ceramic, polymer, composite, bone or other biocompatible materials.

Other features and aspects of the implant body 25 are discussed indetail herein below.

i. Insertion Element

Referring again to FIG. 5A, the implant body 25 includes an insertionelement 650 that includes a flattened elongate insertion plate 45. Theinsertion plate 45 has a medial face 654 and an opposite lateral face656 (not shown) extending the width of the insertion plate 45 as well asopposed edges 658 extending the thickness of the insertion plate 45. Inentering the sacroiliac joint space, the implant body 25 is orientedsuch that its wide medial face 654 and lateral face 656 are orientedgenerally parallel to, and aligned with, the sacroiliac joint line andwithin the joint plane. Within the sacroiliac joint space, the medialface 654 is generally adjacent to the articulating surface of the sacrumand the lateral face 656 is generally adjacent with the articulatingsurface of the ilium.

Referring to FIG. 7A, the insertion plate 45 may have a generallyrectangular side profile (as viewed from a lateral or medial side).According to other embodiments, e.g., FIG. 9, FIG. 39A and FIG. 43A, theinsertion plate 45 may have a generally triangular side profile. Theside profile shape of an insertion plate 45 may be configured to match aportion of the articular surfaces of a sacroiliac joint. For example, agenerally triangle shaped side profile of an insertion plate 45 may bebest suited to match the area footprint of the articular surfaces of thesacroiliac joint, e.g., within an extra-articular space or region, or tosubstantially fill the area footprint of a substantial majority of theentire articular surfaces of a sacroiliac joint. In another aspect, agenerally rectangular side profile may be best suited to match a portionof the articular surfaces within an interarticular region of asacroiliac joint, e.g., a caudal or cranial arm of the interarticularregion. In another aspect, a generally C-shaped or L-shaped side profilemay be selected to be configured to substantially cover an area of thearticular surfaces of the sacroiliac joint within an interarticularregion.

Although the insertion plate 45 illustrated in FIG. 5A has a generallyflat planar profile, in general the insertion plate 45 may have anycontour including, but not limited to curved, corrugated, and any othersuitable contour. In one aspect, the contour of the insertion plate 45may be selected to match the contour of the joint space in thesacroiliac joint within which the insertion plate 45 is to be inserted.In another aspect, a variety of insertion plates 45 may be formed withvarying contours and the contour which best matches the contour of thesacroiliac joint of the patient to be treated is selected for use. Inanother additional aspect, the insertion plate 45 may be formed to bedeformable by the surgeon; in this additional aspect the surgeon maybend or otherwise deform the insertion plate 45 to form an appropriatecontour to match the contour of a patient's sacroiliac joint space,sacral surfaces, and/or iliac surfaces.

FIG. 92 is a side perspective view of an insertion element 650 inanother embodiment. As illustrated in FIG. 92, the insertion element 650may be provided in the form of a threaded cylinder 820. The insertionelement 650 may include threads 822 that extend from the proximal end 43to the distal end 42, thereby allowing the insertion element 650 to beimplanted by twisting the insertion element 650 into a preformed borewithin a joint space. The proximal end 43 of the threaded cylinder mayfurther include a driver tool fitting 824 including, but not limited to,a hexagonal driver head as illustrated in FIG. 92. In anotherembodiment, the proximal end 43 may further include a projectingfastener fitting 826 that may function as an anchor for an element of aspinal support system, or alternatively to fasten an attachment element652 to the insertion element 650. For example, the fastener fitting 826may be threaded (not shown) and may function in a manner similar to aSteffee bolt.

In this embodiment, the threaded cylinder 820 may further include one ormore transverse bores 828 configured to receive one or more additionalfasteners inserted transversely through the surrounding ilium bone in alateral to medial direction, or through the surrounding sacrum bone in amedial to lateral direction in various embodiments. FIG. 93 is across-sectional view of the threaded cylinder 820. As illustrated inFIG. 93, in one embodiment the cylinder 820 may be hollow, and thetransverse bores 828 may direct a fastener along a diameter of the lumento corresponding opposite bores aligned along a diagonal path oppositeto the first transverse bores 828.

FIG. 94A is a side isometric view of the threaded cylinder 820reversibly coupled to a delivery tool 20, and FIG. 94B is an explodedside isometric view of the threaded cylinder 820 reversibly coupled to adelivery tool 20. FIG. 95 is a longitudinal cross-section of thethreaded cylinder 820 reversibly coupled to the delivery tool 20.Referring to FIG. 94A, FIG. 94B, and FIG. 95, the delivery tool 20 mayinclude a cannula 1054 to guide the insertion of the various otherelements of the delivery tool 20. The threaded cylinder 820 may beinserted over the guide pin (not shown) pin or tubular member 1047 inwhich the distal end 832 may be inserted within a joint space (notshown) within which the threaded cylinder 820 is to be inserted. Thedriver tool 838 and associated distal hexagonal socket 834 may beinserted such that the distal hexagonal socket 834 is situated over thedriver tool fitting 824. A first proximal handle 840 provides torque todrive the threaded cylinder 820 into the joint space (not shown). Asillustrated in FIG. 95, a guide ring 835 and associated guide tool 836may be inserted over the driver tool fitting 824 projecting proximallyfrom the proximal end 43 of the threaded cylinder 820. The guide tool836 terminates proximally in a second proximal handle 842.

In another embodiment, FIG. 96 is an isometric view of another implantassembly 15 that includes a threaded conical insertion element 45reversibly coupled to a driver tool 20, wherein the insertion element 45is helically threaded and driven with rotation forces. The distal endregion of the insertion element 45 may be domed. In a particularembodiment, the insertion element 45 may be frusto-conical.

In another example, FIG. 98 is a side view of an implant system in whichan implant body 25 includes multiple implant bodies or pieces 45A and45B (e.g., 2 or 3 or more pieces), thereby permitting motion at asacroiliac joint.

In particular embodiments, the lateral and medial surface contours ofthe insertion plate 45 may be selected to match the contour of the jointspace in the sacroiliac joint within which the insertion plate 45 is tobe inserted. For example, the medial or sacral face 654 of insertionplate 45 may be configured to be generally convex to match the contourof a sacral auricular boney surface or to match the contour of anextra-articular region of a sacrum (e.g., a sacral fossa). In oneaspect, the sacral or medial bone interface surface 654 of the insertionplate 45 may be generally a surface negative of the articular surfaces1016 of the extra-articular space 3007 and/or interarticular region 1044of the sacrum 1004. As another example, the lateral or iliac face 656 ofthe insertion plate 45 may be configured to be generally concave tomatch the contour of an iliac auricular boney surface or to match thecontour of an extra-articular region of an ilium (e.g., an iliactuberosity). In one aspect, the iliac or lateral bone interface surface656 of the insertion plate 45 may be generally a surface negative of thearticular surfaces 1016 of the extra-articular space 3007 and/orinterarticular region 1044 of the ilium 1005.

According to particular embodiments, the insertion element 650 may beconfigured with a distal opening, e.g., which may permit an initialplacement of an anchor 30 (e.g., a screw or rod) into the boneystructure of a patient and then subsequently placement of an insertionelement 650 such that the insertion element 650 at least partiallysurrounds a portion of the anchor 30. For example, the insertion element650 (and associated tooling and systems) may be configured such as thosedescribed in U.S. patent application Ser. No. 14/567,956, filed Dec. 11,2014, entitled “Implants, Systems, and Methods For Fusing a SacroiliacJoint,” which is incorporated herein by reference in its entirety. Forexample, the insertion element 650 may be configured as shown in FIG.5B, defining a distal opening 51 extending distally from a point (e.g.,approximately a midpoint) within the insertion plate 650 through theleading edge 662 of the insertion element 650, as well as extendingthrough both the medial face 654 and the lateral face 656 of theinsertion element 650. In this way, an anchor 30 may be delivered in anumber of trajectories or orientations relative to the distal opening 51and the insertion plate 650. That is, the anchor 30 may be delivereddistal of the distal opening 51 or at any position within the distalopening 51. As far as trajectories, the anchor 30 may be deliveredwithin a range of trajectories relative to the insertion element 650,since the distal opening 51 defines a channel or slot extending distallyfrom a mid-portion of the insertion element 650 to the distal end 662.In another embodiment depicted in FIG. 7F, the insertion element 650defines a distal slot or opening 51 extending distally from a pointwithin the insertion element 650 through a distal end of the insertionelement 650, resulting in two separate leading edges 42. In FIG. 39B,the generally triangular side profile of the insertion plate 45, asdiscussed above in conjunction with FIG. 39A, may also define a distalopening 51 extending from within the insertion plate 45 distally throughan end of the insertion plate 45 between pairs of fins 50 that extendperpendicularly from the medial and lateral faces of the insertion plate45.

According to particular embodiments, the insertion element 650 may becurved or arcuate along its length. The insertion element 650 may beconfigured as in embodiments shown and described in U.S. patentapplication Ser. No. 14/567,956, filed Dec. 11, 2014, entitled“Implants, Systems, and Methods For Fusing a Sacroiliac Joint,” which isincorporated herein by reference in its entirety. For example, theinsertion element 650 may be configured as shown in the embodiments ofFIGS. 7G and 7H. In FIG. 7G, for example, the insertion element 650 iscurved or arcuate within a plane defined by the insertion element 650.In this particular embodiment, when progressing distally along theinsertion element 650, the curve of the insertion element 650 is awayfrom the majority of the attachment element 652. However, the arcuatenature of the attachment element 650 may be in an opposing direction inother embodiments. In this example, the insertion element 650 defines acurved distal opening 51 extending from a point or area within theinsertion element 650 and extending in an arcuate manner through thedistal end of the insertion element 650, resulting in two separateleading edges 42. And, while the embodiment of the insertion element 650in FIG. 7G is arcuate for only a portion of its length between theproximal and distal ends 43, 42, the insertion element 650 mayalternatively be curved along an entire length of the insertion element650 and may define a radial path along the entire length. The curvatureof the insertion element 650 is such that when implanted into thesacroiliac joint, the curvature lies within the plane of the joint. Thatis, concave and convex surfaces of the insertion element 650 lie withinthe plane of the joint.

In FIG. 7H, the insertion element 650 depicted therein is arcuate withina plane defined by the insertion element 650 and exhibits a closedarcuate elongate bore 53 extending proximally and distally along theinsertion element 650. The insertion element 650 also provides a singleclosed distal end 42 directed at an angle relative to the attachmentelement 652. As shown, the angle of the closed distal end 42 relative tothe attachment element 652 may be approximately 45 degrees, but otherangular values may be employed in other examples. As stated with respectto FIG. 7G, the insertion element 650 may be arcuate along its entirelength from the proximal to distal ends 43, 42. Or, the insertionelement 650 may, as shown in FIGS. 7G and 7H, be arcuate for only aportion of the length between the distal and proximal ends 43, 42. It isnoted, that other embodiments of the insertion element may include acurved or arcuate body with or without a distal opening 51. For example,FIG. 39B depicts a delivery tool 20 coupled with the implant assembly 15with an insertion element that includes a distal opening 51. Thisinsertion element may include an arcuate curvature as described withreference to FIGS. 7G and 7H.

1. Fins

In one embodiment, the insertion plate 45 includes a distal or leadingend 42, a proximal end 43, and one or more keels, fins or planar members50 that extend perpendicularly away from the medial face 654 and/orlateral face 656 of the insertion plate 45. The fins 50 typically extendin length from the proximal end 43 to the distal end 42 of the insertionplate 45. In some embodiments, the fins 50 may extend along any one ormore portions of the full distance between the proximal end 43 and thedistal end 42 of the insertion plate 45.

FIG. 6 is a normal cross-sectional view of the insertion plate 45 inFIG. 5A taken at section A-A. Referring to FIG. 6, the fin 50 extendsperpendicularly away from the medial face 654 and a second fin 50Aextends perpendicularly away from the lateral face 656 of the insertionplate 45 in this embodiment. In one embodiment, the fins 50 and 50A maybe grouped into pairs that are generally coplanar with each other, asillustrated in FIG. 6; fins 50 and 50A in this embodiment generallyexist in the same plane. In various other embodiments, the fins 50 and50A may extend in directions that are generally parallel to one another,but not necessarily coplanar as illustrated in FIG. 6. For example, thefin 50 may extend along a plane that is parallel but offset from theextension plane of the second fin 50A.

In various embodiments, the number of fins 50 extending from the medialface 654 and/or lateral face 656 of the insertion plate 45 may varywithout limitation. The number of fins 50 extending from the medial face654 need not be equal to the number of fins 50 extending from thelateral face 656. In one aspect, all fins 50 may be identical incross-sectional size and shape. In other aspects, one or more fins 50may differ in cross-sectional size and shape.

Referring again to FIG. 6, the width W₁ of the insertion plate 45extending between the opposed edges 658 may range from approximately 5mm to approximately 30 mm in one embodiment. In another embodiment, thethickness T₁ of the insertion plate 45 between the medial face 654 andthe opposite lateral face 656 may range from approximately 2.5 mm toapproximately 15 mm. The overall length of the insertion plate 45extending from the proximal end 43 (not shown) and the distal end 42(not shown) may range between approximately 5 mm and approximately 70mm. In other embodiments, W₁ may vary at or between ends 42 and 43.

In an additional embodiment, the perpendicular extension distance D₁ ofthe fins 50 measured relative to a plane 660 situated midway between themedial face 654 and lateral face 656 and parallel to both faces 654/656may range between approximately 2.5 mm and approximately 18 mm. Thethickness T₂ of the one or more fins 50 width may range fromapproximately 1 mm to approximately 10 mm.

In these various aspects, the dimensions of the insertion plate 45 andassociated one or more fins 50 can and will vary based on variousaspects. The thickness T₁ of the insertion plate 45 may be selected toexert firm pressure against the articulating surfaces of the sacrum andilium within the joint space without undue stretching or distortion ofthe sacroiliac joint and surrounding soft tissues. The width W₁ of theinsertion plate 45 may be selected to fit within the sacroiliac jointalong the joint line, and to provide sufficient structural integrity tothe insertion plate 45 while minimizing the extent of bone and softtissue removal needed to prepare the sacroiliac joint to receive theinsertion plate 45.

The perpendicular extension distance D₁ of the one or more fins may beselected to result in the incursion of the one or more fins 50 into thearticulating bone surfaces within the sacroiliac joint in order tofacilitate the integration of bone tissue into the surface of theinsertion plate 45. In addition, the perpendicular extension distanceD₁, fin thickness T₂, and/or length of the one or more fins 50 may beconfigured to provide structural reinforcement to the insertion plate 45to resist deflection in any direction. In one embodiment, the one ormore fins 50 may provide structural reinforcement against bendingdeflections in the medial and/or lateral directions.

In another example, while the insertion element 650 of FIG. 5B isdepicted as not employing the fins 50 of FIG. 5A, other examples of theinsertion element 650 may employ both a distal opening 51 and one ormore fins 50.

2. Tapered Distal End

Referring back to FIG. 5A, the distal end 42 of the insertion plate 45may taper in a pointed end, a bullet nose, or any other otherwiserounded configuration, wherein the rounded configuration extends outwardaway from the distal extremity of the insertion plate 45 and along thedistal or leading edge 662 of the insertion plate 45 as well as thedistal or leading edge 57 of the one or more fins 50. FIG. 7 is a sideview of the implant body 25 looking toward the medial face 654 of theinsertion plate 45. FIG. 8 is a second side view of the insertion body25 looking toward one of the edges 658 of the insertion plate 45. Thus,as can be understood from FIGS. 5 and 7, 9-13, the leading or distaledge 42 of the insertion plate 45 and the leading edge 57 of the fins 50may be rounded in the radially extending length of the lead or distaledges and/or in a direction transverse to the radially extending lengthof the lead or distal edges. In one embodiment, the leading edges 57 ofthe fins 50 may each have a radius R₂ ranging from approximately 1 mm toapproximately 15 mm and the leading edge 42 of the insertion plate 45may have a radius R₁ ranging from approximately 1 mm to approximately 15mm. In another embodiment, the leading edge 42 of the insertion plate 45and the leading edges 57 of the fins 50 may have a generally conicalpointed configuration, a polygonal configuration, or an elliptical domeconfiguration.

3. Delivery Tool Fittings

As indicated in FIGS. 5, 7, and 8 the proximal end 43 of the insertionplate 45 may have a generally planar face that is generallyperpendicular to a proximal-distal center axis CA of the insertion plate45 in one embodiment. Referring back to FIG. 5A, the generally planarface of the insertion plate 45 may facilitate the secure attachment ofthe implant assembly 15 to the distal end 35 of the delivery tool 20,which may have a generally planar distal face (not shown). In otherembodiments, the proximal end 43 of the insertion plate 45 may becontoured to match a corresponding contour of the distal face of thedelivery tool 20. For example, the proximal end 43 of the insertionplate may have a domed contour that matches a corresponding cuppedcontour of the distal face of the delivery tool 20, or vice-versa.

In various embodiments, the proximal end 43 of the insertion plate 45may define or contain one or more additional features to effectuate areversibly locked engagement with the distal end 35 of the delivery tool20. Referring back to FIG. 5A, a center attachment bore 70 may bedefined in the proximal end 43 of the insertion plate 45 in oneembodiment; this center attachment bore 70 may be centered about thelongitudinal center axis CA. In one embodiment, the center attachmentbore 70 may be a blind hole in that it only has a single opening.Alternatively, the center attachment bore 70 may be configured as a holethat communicates between the proximal end 43 and distal end 42 of theinsertion plate 45. Bore 70 may alternatively or additionallycommunicate with the lateral or medial surfaces of an insertion element650 in order to permit the introduction by injection, or by any otherknown means of introduction, of stem cells or other biocompatiblematerial up to or near the joint surfaces via the bore 70. The centerattachment bore 70 may further incorporate additional features toreceive an element of the delivery tool 20 in a reversibly lockedengagement. For example, the center attachment bore 70 may containthreads matched to the threads of a set screw used to secure the distalend 35 of the delivery tool 20 to the implant assembly 25.

In other embodiments, the proximal end 43 of the insertion plate 45 mayinclude additional features to further enhance the reversibly lockedengagement with the delivery tool 20. In one embodiment, the proximalend 43 may contain one or more additional lateral attachment bores 75(not shown) offset from the center bore 70. These lateral attachmentbores 75 may be threaded to receive one or more additional set screws inan embodiment. In another embodiment, these lateral attachment bores maybe shaped to match corresponding alignment pegs protruding from thedistal end 35 of the delivery tool 20.

In other additional embodiments, protruding or recessed elementssituated on or within the implant assembly 15 may be configured tointerface with pliers, hemostats or other delivery tool configurations.FIG. 97A is an isometric view of a hemostat-type of delivery device 20.FIG. 97B is a close isometric view of the jaws 902 of the deliverydevice 20. As illustrated in FIG. 97B, each of the jaws 902 terminatedistally in a projecting alignment peg 904 that fits within a recessedelement or other tool attachment fittings formed in or on the implantbody 25. The locked engagement of the alignment pegs 904 within therecessed elements or other tool attachment fittings resists any tendencyfor the implant body 25 to rotate during insertion into a joint spaceusing the delivery tool 20. FIG. 12 illustrates an implant body 25 thatincludes a recessed element 154 suitable for use with the hemostat-typeof delivery device 20 illustrated in FIG. 97A-B.

FIG. 9 is an isometric view of a second embodiment of an implant body25. In this embodiment, an additional lateral attachment bore 75 isprovided in the form of an alignment peg receptacle. This alignment pegreceptacle 75 may be a blind hole configured to receive an alignment pegprotruding from the distal end 35 of the delivery tool 20 (not shown).

In one embodiment, the center bore 70 may have a diameter ranging fromapproximately 2 mm to approximately 10 mm. In another embodiment, theone or more lateral attachment bores may each have a diameter rangingfrom approximately 0.5 mm to approximately 3 mm.

FIG. 10A is a top view of the first embodiment of the implant body 25illustrated in FIG. 5A. In an embodiment, the outer contour 664 of theproximal end 43 of the insertion plate 45 may be contoured to fit withintwo or more additional alignment pins 150 protruding in a distaldirection from the distal end 35 of the delivery tool (not shown). FIG.10B is the top view of the implant body 25 illustrated in FIG. 10A withthe distal end of the delivery tool 20 mounted in place. In thisembodiment, the additional alignment pins 150 project in a distaldirection to entrap the lateral margin of the proximal end 43. In thisconfiguration, the additional alignment pins 150, in cooperation with aset screw 95 advanced into the central bore 70 of the implant body 25,secure the delivery tool 20 to the implant body 25 and prevent thedelivery tool 20 from translating or rotating relative to the implantbody 25.

In an embodiment, the implant body 25 is fixed in place within the jointspace of the sacroiliac joint by means of an anchor 30 directed througha bore 40. In another embodiment, the insertion plate 45 may furtherinclude one or more additional bores 670. The additional bores 670 maybe directed through the corner formed by the attachment element 652 andthe insertion element 650 as illustrated previously in FIG. 5A.Referring to FIG. 10A and FIG. 10B, the additional bores 670A and 670Bmay be accessed via anchor guides 1082 and 1084, respectively. In thisembodiment, the anchor guides 1082 and 1084 may direct the anchors 30along a direction consistent with the central axes of the additionalbores 670A and 670B. FIG. 11A is a lateral side view of the implant body25 viewing the lateral face 656 of the insertion plate 45 in oneembodiment. In this embodiment, one or more bores 670 may be formed inthe insertion plate. The one or more additional bores 670 may be openbores passing through the insertion plate 45 in one aspect. In anotheraspect, the one or more additional bores 670 may be blind bores openingto the medial face 654 and/or opening to the lateral face 656. Forexample, the one or more additional bores 670 may be blind bores openingto the lateral face 656 of the insertion plate 45 as illustrated in FIG.11A.

The one or more additional bores 670 may be provided with anycross-sectional profile and dimension without limitation. In oneembodiment, each of the one or more additional bores 670 may have across-sectional profile that is square, rectangular, circular, oval,triangular and any combination thereof. For example an additional bore670 may have a round cross-sectional profile within a first bore segmentand transition to a round cross-sectional profile in a second boresegment. In another embodiment, one or more additional bores 670 may befurther configured to permit an anchor 30 directed through a bore 40 tobe further advanced through a bore 670, which is substantially greaterthan the diameter of the anchor 30, within a predetermined range oftrajectories. In this other embodiment, the anchor 30 may be inserted asselected by a surgeon within a predetermined range of trajectories atthe time of implantation while still passing through a bore 40 andfurther through an additional bore 670. For example, as illustrated inFIG. 43 and described herein below, a second anchor arm 115B may includea conical sleeve 165B that effectuates the insertion of an anchor 30within a predetermined range of anchor insertion angles; thispredetermined range of insertion angles may be constrained by thecontour of the conical sleeve 165B, as well as by the location andcross-sectional profile of the bore 40 and/or the location andcross-sectional profile of any additional bores 670. The conical sleeve165B may be included in the delivery device 20 to facilitate theplacement and insertion of fasteners in which some latitude in placementmay be desired. Furthermore, the one or more additional bore 670 mayprovide an open channel, pathway, other connection to permit bone growthbetween a sacrum 1004 and ilium 1005 through one of more elements of theimplant body 25, including, but not limited to, the insertion element650. In various embodiments, the conical sleeve 165B may be configuredto guide the trajectory of any suitable fastener including, but notlimited to, polyaxial bone fasteners and pedicle screws.

4. Additional Fastener Bores

Each of the one or more additional bores 670 may be configured toreceive an orthopedic fastener including, but not limited to a screw, apin, or any other known orthopedic fastener. In one aspect, if the oneor more additional bores 670 may be blind bores, each additional bore670 may be configured to receive the distal end or tip of the orthopedicfastener; in this aspect, each additional bore may be provided with alocking mechanism to mechanically retain the shaft, distal end, and/ortip of the orthopedic fastener. In another aspect, if the one or moreadditional bores 670 may be open bores, each of the additional bores 670may be configured to receive a center portion of the shaft of theorthopedic fastener. In this other aspect, the diameter of eachadditional bore 670 may be sized to allow the passage of the shaft ofthe orthopedic fastener with little mechanical play to restrict theorientation the orthopedic fastener relative to the insertion plate 45.Alternatively, the diameter of each additional bore 670 may permit somedegree of mechanical play in order to permit a limited variation in theorientation of the orthopedic fastener relative to the insertion plate45.

In one embodiment, the orientation of the bore axis of each additionalbore 670 may be aligned perpendicular to the medial face 654 and/orlateral face 656 of the insertion plate 45, as illustrated in FIG. 11A.In other embodiments, the bore axis of each additional bore may have anyorientation without limitation. In general, the orientation of the oneor more additional bores 670 may be selected in order to facilitate theincorporation of additional orthopedic fasteners directed mediallytoward the implant body 25 from the ilium and/or directed laterallytoward the implant body 25 from the sacrum. For example, an orthopedicfastener may be directed from the ilium, through an additional open bore670, and into the sacrum; the fastener may enhance the anchoring of theimplant body 25 within the joint space of the sacroiliac joint as wellas strengthening the fusion and fixation of the sacroiliac joint andsubsequent spinal construct from the lumbar spine.

In an additional embodiment, an additional bore 670 may be an open boreconfigured to guide the anchor 30 in cooperation with the bore 40 withinthe attachment element 652 of the implant body 25. FIG. 13A is a sideview of an implant body 25 with an anchor 30 inserted though the bore 40in the attachment element 652 and additionally through the additionalbore 670 in the insertion plate 45. As illustrated in FIG. 13A, thealigned bore axes of the bore 40 and the additional bore 670 areconfigured to guide the anchor 30 into the underlying bone tissue at alaterally-directed downward angle. In general, the bore axes of the bore40 and the additional bore 670 may be aligned at any angle withoutlimitation, constrained only by dimensions of the insertion element 650and the attachment element 652 of the implant body 45.

In another embodiment, illustrated in FIG. 5A, additional bores 670A and670B may be at least partially directed through the corner formed by theattachment element 652 and the insertion element 650. The additionalbores 670A and 670B are configured to guide the anchor 30 into theunderlying bone tissue at a laterally-directed downward angle. Theadditional bores 670 in this embodiment may be threaded as illustratedas additional bore 670A or unthreaded as illustrated as additional bore670B in FIG. 5A.

In an additional embodiment, illustrated in FIGS. 134-138, the insertionelement may include an additional bore 40B that is aligned with the boreaxis of a second bore 40 formed in the insertion element 652. Incombination, bores 40 and 40B are configured to guide the anchor 30 intothe underlying bone tissue at a laterally-directed downward angle.

In other additional alignments, the additional bores 670 may be openbores formed within additional attachment plates of various sizesprojecting in various orientations relative to the attachment element652 of the implant body 45. In one aspect, illustrated in FIG. 7B, theattachment element 652 may include an additional attachment plate 794containing one or more additional bores 796; an anchor 30 may beinserted through each additional bore 796 to secure the implant assembly25 in place. The additional attachment plate 796 may vary in length andmay be relatively short as illustrated in the additional attachmentplate 796 shown in solid lines in FIG. 7B or may extend up to the fullextent of the edge of the implant assembly 25 from which the additionalattachment plate 794 projects.

In these other additional aspects, the additional attachment plate 794may contain one or more additional bores 796. By way of non-limitingexample, the additional attachment plate 794 may include a singleadditional bore 796 as illustrated in FIG. 7B. By way of anothernon-limiting example, the additional attachment plate 794 may includemultiple additional bore 796A-796B as illustrated in FIG. 7C.

Also in these additional other aspects, the additional attachment plate794 may project at a variety of orientations relative to the attachmentelement 652 of the implant body 45. In one aspect, the additionalattachment plate 794 may project in a proximal direction as illustratedin FIG. 7B and FIG. 7C, as well as in side view in FIG. 8B. In this oneaspect, the additional bore axis 798 is essentially perpendicular to theproximal-distal center axis CA. In a second aspect, illustrated in FIG.8C the additional attachment plate 794 may project at an angle such thatthe additional bore axis 798 is shifted an angle 800 away fromperpendicular to the proximal-distal center axis CA. In a third aspect,the additional attachment plate 794 may project in a cranial or caudaldirection as illustrated in FIG. 7D and the additional bore axis 798 maybe deflected at an angle 802 relative to the proximal-distal center axisCA.

The angle at which the additional attachment plate 794 projects may bepreformed in the implant assembly 25, or the angle may be set and oradjusted by deforming the additional attachment plate 794 along the edgeat which the additional attachment plate 794 joins the attachmentelement 652. By way of non-limiting example, a surgeon may select animplant assembly 25 with a preformed additional attachment plate 794 inorder to achieve a closer fit of the regions of the implant assembly 25with the local topology of the underlying bone tissue. In anothernon-limiting example. a surgeon may iteratively deform an additionalattachment plate 794 during a surgical procedure in order to fine-tunethe closeness of fit of the implant assembly 25 within the surgicalregion.

In various other aspects, the additional attachment plate 794 may benon-planar and may contain accessory bores configured to containaccessory fasteners used for purposes other than securing the implantassembly 25 in place. In one aspect, the additional attachment plate 794may project in a curved profile as illustrated in FIG. 7E. In thisexample, the curved additional attachment plate 794A may contain anaccessory bore 804 configured to receive a set screw or pin 806. Asillustrated in FIG. 7E, the curved additional attachment plate 794A mayform a fitting within which a rod 2096 or other element of a spinalstabilization system may be secured using the set screw or pin 806.

In yet other additional embodiments, the additional bore 670 may beprovided within certain elements of the implant assembly 15 that mayrequire alignment in addition to the alignment inherently provided bythe delivery tool. In one embodiment, illustrated as cranial and sideviews in FIG. 13B and FIG. 13C, the implant assembly 15 may include ananchor 30 inserted through a bore 1302 formed through a rotatableinsertion element 1300. The rotatable insertion element 1300 may behelically threaded as illustrated in FIG. 13B and may be driven into thejoint space of the sacroiliac joint using torques delivered by aninsertion tool (not shown). In this embodiment, an indicator 1304 may beprovided to indicate an alignment of the bore 1302 of the rotatableinsertion element 1300 with a bore 40 of the attachment element 652.

ii. Attachment Element

Referring back to FIG. 5A, the implant body 25 may further include anattachment element 652 configured to provide a guide 505 for theattachment fitting 500 that provides robust mechanical anchoringthroughout a predetermined range of positions and orientations. Inaddition, the attachment element 652 is configured to receive the anchor30 through a bore 40 formed in the attachment element 652. The bore 40permits the insertion of the anchor 30 through the implant body 25 andinto the underlying bone tissue at a predetermined range of positionsand orientations.

In one embodiment, the attachment element 652 may include a lateral edge672 that is mechanically attached to the proximal end 43 of theinsertion element 650. In another embodiment, the attachment element 652may include a medial edge 671 that is mechanically attached to theproximal end 43 of the insertion element 650. In an additionalembodiment, the lateral edge 672 of the attachment element 652 may bewelded, glued, joined using fasteners such as screws, or otherwisepermanently attached at a fixed position and angle to the proximal end43 of the insertion element 650 as illustrated in FIG. 5A. In anotherembodiment, the attachment element 652 and the insertion element 650 maybe formed as a single integrated structural element. In yet otherembodiments, the lateral and/or medial edges of the attachment element652 may be attached to the proximal end 43 of the insertion element 650in a hinged attachment such that the angle formed between the insertionelement 650 and the attachment element 652 may be varied within apredetermined range prior to fixing within the sacroiliac joint space toaccommodate variations in patient morphologies.

FIG. 8 illustrates the angle θ formed between the insertion element 650and the attachment element 652. In various embodiments, this angle θ mayrange between approximately 30° and approximately 120° to accommodate arange of patient morphologies. In one embodiment, the angle θ may beapproximately a right angle, or may be approximately 90°, as illustratedin FIG. 8. Any intersection between attached edges of various elementsof the implant body including, but not limited to, the insertion element650 and the attachment element 652 may include filleting, chamferingand/or ribbing along the interior and/or exterior corners.

In one embodiment, a variety of implant bodies 25 with a range of anglesθ may be provided, and an implant body 25 with a particular angle θ thatmost closely matches the morphology of the patient to be treated may beselected for use. In another embodiment, a single implant body 25 inwhich the lateral or medial edge of the attachment element 652 and theproximal end 43 of the insertion element 650 are attached in a hingedattachment may provide a variable angle θ that may be customized to bestaccommodate the patient's morphology during the insertion of the implantbody 25 into the sacroiliac joint space of the patient. In yet anotherembodiment, an implant body 25 with an initial angle θ in which theimplant body 25 may be elastically and/or plastically deformed to alterthe angle θ within a predetermined range (e.g., by a medical person) maybe provided to the surgeon. In this other embodiment, a practitionerincluding, but not limited to a surgeon or other medical person, anapparatus, a surgical robot or a computer controlled device may deformthe implant body 25 to accommodate the patient's morphological variationprior to inserting the implant body 25 into the sacroiliac joint spaceof the patient.

1. Anchor Fitting

In various embodiments, the attachment element 652 may include an anchorfitting 40 configured to receive an anchor 30. The anchor fitting 40mechanically interacts with the anchor 30 to mechanically fix theinsertion plate 45 within the sacroiliac joint space of the patient.Referring back to FIG. 5A, the anchor fitting 40 may be provided in theform of an open bore 40. In one embodiment, the open bore 40 may beprovided with a bore diameter sufficiently large to permit limitedmechanical play such that the anchor 30 may be inserted through the bore40 throughout a range of insertion angles. In another embodiment, one ormore portions of the attachment element 652 situated near an anchorfitting 40 may be further configured like a Steffee plate. In variousother embodiments, the bore 40 may have any cross-sectional profilewithout limitation. Non-limiting examples of cross-sectional profilessuitable for the bore 40 include: circular, oval, slotted, square,rectangular and/or any combination and permutation of anycross-sectional profile.

FIG. 14 is a side view of a section of the attachment element 652showing the anchor 30 inserted through the anchor fitting 40 in oneembodiment. As illustrated in FIG. 14, the anchor may be inserted at anyof a variety of insertion angles φ. The insertion angle φ, as definedherein refers to an angle relative to a perpendicular axis PA alignedperpendicular to the attachment element 652. In one embodiment, theattachment element 652 may be provided with a non-planar or contouredprofile; in this embodiment, the perpendicular axis PA may be alignedperpendicular to a region of the attachment element 652 in closeproximity to the bore 40. In another embodiment, the insertion angle φmay range between approximately 0° (i.e. perpendicular to the attachmentelement 652) and approximately 45°. In another embodiment, the insertionangle φ may be directed in any direction without limitation including,but not limited to anterior, lateral, medial, cranial, caudal, anterior,posterior, ventral, dorsal, and any intermediate direction withoutlimitation. Other desired trajectories and starting locations arediscussed throughout herein.

In various embodiments, the anchor insertion angle may be constrained tovarying degrees by variations in the cross-sectional profile of the bore40. FIGS. 16A-16D are a series of cross-sectional views of thecross-sectional anchor bores 40 in various embodiments. In oneembodiment, the bore 40 may be a vertical bore with a constant diametercross-sectional profile as illustrated in FIG. 16A; an anchor 30 isshown inserted in the bore 40 to provide the orientation of the view.FIG. 16B illustrates an angled bore 40 with a constant diametercross-sectional profile. The embodiment illustrated in FIG. 16C is abore 40 that includes a hemispherical cross-sectional profile configuredto permit a wider range of anchor insertion angles. FIG. 16D isillustrates a bore 40 that includes a conical cross-sectional profileconfigured to permit a wider range of anchor insertion angles.

Referring to FIGS. 9 and 13, the anchor fitting 40 may act incooperation with an additional bore 670 formed in the insertion element652 as described previously herein. In this embodiment, the insertionpath of the anchor 30 through the bore 40 and additional bore 670 maypermit relatively limited mechanical play, thereby constraining theanchor insertion angle to a relatively narrow range. In anotherembodiment, the additional bore 670 may be provided in the form of aslot to provide for a wider range of mechanical play and permittedanchor insertion angles.

In various embodiments including, but not limited to the implant bodies25 illustrated in FIG. 5A and FIG. 9, the anchor fitting 40 may beprovided as a bore, a slot, or any other suitable fastener guide formedin an essentially planar material. In various other embodiments, theanchor fitting 40 may be a discrete structure mechanically attached toan anchor support element of the attachment element 652. Referring backto FIG. 12, the anchor fitting 40 may be provided in the form of ananchor socket 40 mechanically attached to an anchor support element 674.In this embodiment, the anchor socket 40 may be configured to permitanchor insertion angles through a relatively wide range of angles anddirections. FIGS. 15A-15C are top views of the implant assemblyillustrated in FIG. 12, illustrating anchors 30 inserted into anchorsockets 40 at a variety of anchor insertion angles and directions. Theanchor 30 may be inserted at a relatively vertical insertion angle asillustrated in FIG. 15A, in a more medial direction as illustrated inFIG. 15B, or in a more lateral direction as illustrated in FIG. 15C.

The anchor support element 674 is configured to mechanically hold theanchor fitting 40 in a fixed position and orientation in variousembodiments. In one embodiment, the anchor fitting 40 may be attached ina fixed position to the anchor support element 674. Referring back toFIG. 12, the anchor support element 674 may have a rectangularcross-sectional profile to provide a fixed support for the anchorfitting 40 that is resistant to rotation. In general, the anchor supportelement 674 may have any cross-sectional shape without limitation. Inanother embodiment, the anchor support element 674 may have a circularcross section to permit the rotation of the anchor fitting 40 about theanchor support element 674 to permit a wider range of anchor insertionangles and directions.

In one embodiment, the anchor fitting 40 may be provided with additionalanchor retention features to retain the anchor 30 in place duringlong-term use of the implant assembly 15. As illustrated in FIG. 17,which is an enlarged view of the anchor fitting 40, the anchor fitting40 has a plurality of arcuate members 320 distributed along an innercircumferential boundary 325 of a rim 330 of the anchor fitting 40.There may be five or more or less arcuate members 320 distributedgenerally evenly about the inner circumferential surface 325 of the rim330.

In one embodiment, each arcuate member 320 has ends 332 that intersectthe inner circumferential surface 325 of the rim 330, with a centerpoint 335 of the arcuate member 320 that is offset or spaced apart frominner circumferential surface 325 of the rim 330. Thus, in oneembodiment, the arcuate members 320 may be deflectable so as to allowthe head of the anchor member 30 (not shown) to pass between the centerpoints 335 of the members 330 as the head of the anchor member 30 isseated in the anchor fitting 40. As a result, the arcuate members 320can act against the head of the anchor member 30 to prevent the anchormember 30 from working its way out of the anchor fitting 40 and opening315 of the implant body 25, thereby serving as an anchor member lockingmechanism.

In another embodiment, the anchor fitting 40 may be provided withadditional anchor retention features, such as a set screw, to retain theanchor 30 in place during long-term use of the implant assembly 15.

2. Anchor

Referring again to FIG. 4 and FIG. 5A, an anchor 30 may be used tomechanically fix the insertion blade 45 of the insertion element 650within the joint space of the sacroiliac joint in various embodiments.The anchor 30 may be in the form of an elongated body such as, forexample, a nail, rod, pin, threaded screw, expanding body, a cable(e.g., configured with a ball end), etc. The anchor element 30 isconfigured to be received in a bore 40 defined through the implant body25. According to particular embodiments, the anchor 30 includes a flangelocated proximal to a threaded portion and protruding beyond the mainanchor shaft diameter and sized larger than the attachment element borein order to resist pullout and may further include a proximal endconfigured to allow the attachment of an attachment fitting including,but not limited to a poly-head attachment fitting.

In one embodiment, the anchor 30 may be a bone screw. Any suitableorthopedic-grade bone screw may be used as the anchor 30 including, butnot limited a cortical screw, a cancellous screw, a Steffee screw, andany other suitable orthopedic bone screw. FIG. 30 is a side view of ananchor 30 in one embodiment. The anchor 30 may include a head 302 and ashaft 304. In various embodiments, the shaft 304 may be threaded alongthe full length of the shaft. The threads may be configured forinsertion into cortical bone and/or cancellous bone in various otherembodiments. The threads and/or shaft may be tapered. In various otherembodiments the anchor 30 may be cannulated along the longitudinal axisof the anchor 30. Additionally, the anchor 30 may be provided with bonewindows communicating with the lumen of the cannulated anchor 30.

In one embodiment, the shaft 304 may contain one or more threadedsegments including, but not limited to a proximal threaded segment 306and a distal threaded segment 308 as illustrated in FIG. 30. The shaft304 may further include one or more non-threaded segment 310. In oneembodiment, the non-threaded segment may be situated between theproximal threaded segment 306 and the distal threaded segment 308, asillustrated in FIG. 30. FIG. 31 is a side view of an another embodimentof the anchor 30, in which the non-threaded segment 310 is situatedbetween the head 302 and the distal threaded segment 308; thisembodiment may function as a lag screw.

Referring back to FIG. 30, the proximal threaded segment 306 and thedistal threaded segment 308 may include similar thread patterns ordissimilar thread patterns according to the intended use of the anchor30. The anchor 30 may be inserted within the sacrum 1004, which containslargely cancellous bone and may be additionally be inserted within theilium, which contains cortical bone. In addition, the anchor 30 mayreceive additional threaded fasteners including but not limited tothreaded nuts, threaded sleeves, and other threaded fittings associatedwith elements of the spinal stabilization system. In variousembodiments, one or more washers including, but not limited to curvedwashers and/or locking washers may be used in conjunction with theanchor 30 and/or any additional threaded fasteners. In variousembodiments, the one or more threaded segments may be provided with anyone or more thread patterns including, but not limited to a corticalthread pattern, a cancellous thread pattern, a metal screw threadpattern, and any other appropriate thread pattern known in the art.

In one embodiment, the proximal threaded segment 306, which may besituated within the sacrum, may be provided with a cancellous threadpattern, as illustrated in FIG. 30. In this same embodiment, the distalthreaded segment 308, which may be situated within the ilium, may beprovided with a cortical thread pattern.

The anchor 30 may further include a tip 312 situated on a distal end ofthe shaft 304 opposite to the head 302. In one embodiment, the tip 312may be a rounded tip as illustrated in FIG. 30. In other embodiments,the tip 312 may be self-tapping tip or any other suitable tip for anorthopedic bone screw known in the art.

The head 302 of the anchor 30 may be provided with any known screw headshape including, but not limited to: round, flat, hexagonal, square, andany other known screw head shape. Referring back to FIG. 30, the head302 may be a round head in one embodiment. A top view of the head 302 isillustrated in FIG. 32. The head 302 may include a screwdriver fitting314 configured to receive a screwdriver blade or fitting. Thescrewdriver fitting shape may be any known fitting shape including, butnot limited to: a single slot, a cross insert (Phillips head fitting), ahexagonal inset, a star-shaped inset (TORX fitting), and any other knownfitting shape.

In an additional embodiment, the anchor 30 may be a Steffee-type screw,as illustrated in side view in FIG. 33. The Steffee-type anchor 30 mayinclude the shaft 304, the distal threaded portion 308, and the distaltip 312, as in previous anchor 30 embodiments. In addition, theSteffee-type anchor may include a driver segment 316 configured to becompatible with a known screw driving or bolt insertion tool including,but not limited to, a wrench. For example, the driver segment 316 mayhave a hexagonal cross-section, thereby rendering the driver segment 316compatible with a hexagonal wrench. In addition, the Steffee-type anchor30 may include a threaded attachment segment 318 ending in a headlessproximal end 324. The headless proximal end provides the ability foradditional fastener elements to be attached to the threaded attachmentsegment 318 including, but not limited to a first nut 320 and/or and asecond nut 322.

FIG. 34 is a side view of the Steffee-type anchor 30 installed throughthe bore 40 of an implant body 25 to fix the implant body to theunderlying bone tissue. In use, the distal threaded portion 308 may beinserted into the underlying bone tissue using a tool such as wrenchattached to the driver segment 316. Once the anchor 30 is situated inplace, the implant body 25 may be situated over the protruding distalthreaded portion 308 of the anchor such that the bore 40 is centeredover the distal threaded portion 308. The implant body 25 may then besituated such that the insertion element 650 is situated within thejoint space of the sacroiliac joint. One or more fasteners, such as thesecond nut 322 may be installed on the distal threaded portion 308 suchthat the attachment element 652 is sandwiched between the driver segment316 and the second nut 322, as illustrated in FIG. 34.

In one aspect, the anchor 30 and associated fasteners such the first andsecond nuts 320 and 322 may be machined, molded, formed, or otherwisemanufactured from stainless steel, titanium, ceramic, polymer,composite, bone or other biocompatible materials. The material of theanchor 30 may be compatible for continuous contact with the implant body25 and associated fasteners.

3. Attachment Fitting

In addition to the anchor fitting 40, the attachment element 652 furtherincludes at least one attachment fitting 500 in various embodiments.Referring back to FIG. 3, the at least one attachment fitting 500 isconfigured to attach to an element of a spinal stabilization systemincluding, but not limited to, a rod 2096 in a locked mechanicalposition, thereby providing robust anchoring to the spinal stabilizationsystem. In various embodiments, the at least one attachment fitting 500may be provided with one of more features to facilitate the positioningand orientation of the rod 2096 or other element of the spinalstabilization system; typically these one or more features may providethe ability to translate and rotate the attachment fitting in a varietyof different directions. In various other embodiments, the at least oneattachment fitting 500 is configured to be located on and/or supportedoff attachment element 652. For example, the attachment fitting 500 maybe provided as a monoaxial or polyaxial attachment fitting 500 and theassociated attachment element 652 may be configured substantially as amonolithic structural element.

In various embodiments, the attachment fitting 500 is configured to bereceived by a guide 505 formed within attachment element 652. The guide505 is configured to effectuate limited translational and rotationalmovements of the attachment fitting 500 prior to engagement of theattachment fitting 500 with the element of the spinal stabilizationsystem. In addition, the guide 505 is configured to lock the attachmentfitting 500 in a fixed position and orientation when the element of thespinal stabilization system is locked into place within the attachmentfitting 500.

Referring to FIG. 9, the attachment fitting 500 may be a head 676 of apolyaxial orthopedic fastener 678 including, but not limited to apedicle screw. In this embodiment, the polyaxial screw 678 may beinserted through a guide 505 in the form of a bore 680. In thisembodiment, the bore 680 is similar to the anchor bore 40 illustratedpreviously in FIG. 5A and discussed herein above. The cross-sectionprofile of the bore 680 may be a slanted profile, as illustrated in FIG.9, or any other cross-sectional profile discussed herein above for theanchoring bore 40 and illustrated in FIGS. 16A-16D. The cross-sectionalprofile of the bore 680 may be configured to permit the insertion of thepolyaxial orthopedic fastener 678 within a predefined range of fastenerangles and directions. In addition to providing an attachment point foran element of the spinal stabilization system, the polyaxial screw mayfurther supplement the implant holding force provided by the anchor 30.

FIG. 18 is a side view of a polyaxial screw 678 in one embodiment. Thehead 676 may be provided in the form of a tulip-like head 676 in oneembodiment. In this embodiment, the head 676 may include at least twosupport elements 2812 and 2814 forming the sides of at least oneupward-opening groove 2816. The head 676 may further include acompression element 2818 forming the bottom surface of the groove 2816.The inner surfaces of the at least two support elements 2812 and 2814may further form a threaded fitting 2820 into which a threadedcompression nut 2822 may be inserted during use.

In this embodiment, the head 676 may be attached to the top end 2806 ofthe shaft 2804 such that the head 676 may rotate freely about alongitudinal axis of the shaft 2804 and/or in additional directionsoffset from the longitudinal axis of the shaft 2804. In use, a rod 2096(not shown) may be situated within the groove 2816. The compression nut2822 may be situated within the threaded fitting 2820 and advanced untilthe reinforcing element is held fixed between the compression nut 2822and the compression element 2818. In another aspect, the introduction ofa compressive force onto the compression element 2818 by the compressionnut 2822 via the reinforcement element may further introduce a holdingforce within the attachment of the head 676 to the top end 2806 of theshaft 2804 such that the head 676 may no longer rotate freely.

In one aspect, the polyaxial screw 678 may be machined, molded, formed,or otherwise manufactured from stainless steel, titanium, ceramic,polymer, composite, bone or other biocompatible materials. The materialof the polyaxial screw 678 may be compatible for continuous contactmaterial with the implant body 25.

Referring back to FIG. 4, the attachment fitting 500 may be provided inthe form of a dedicated attachment fitting 500 in another embodiment.The attachment fitting 500 includes a tulip-head fitting similar to thehead 676 of the polyaxial screw 678 described herein previously. In thisother embodiment, the attachment fitting 500 is configured to translatewithin a guide 505 in the form of a slot 680. Referring back to FIG. 5A,the slot 680 includes an opening 682 passing through the attachmentelement 652. The slot 680 further includes a raised rim 684 protrudingin a proximal direction from the attachment element 652 and forming theperimeter of the slot 680.

The slot 680 may define any shape of pathway without limitationincluding, but not limited to: a straight line; a curve or arc; and anycombination thereof. Referring again to FIG. 5A the slot dimensions mayinclude a slot width SW, a slot height SH, and any other relevant slotdimension (not shown) including, but not limited to: slot length, slotcurvature, slot orientation, and any other relevant slot dimension. Inone aspect, the slot dimensions may be selected to be compatible withelements of the attachment fitting 500.

FIG. 19 is an isometric view of the attachment fitting 500 in oneembodiment. FIG. 20 is a close-up side view of the attachment fitting500 in this embodiment. Referring to FIGS. 19 and 20, the attachmentfitting 500 may include at least two support elements 686 and 688forming the sides of at least one upward-opening groove 690. In additionat least two support elements 686 and 688 may be configured to receive alocking nut 696 in a threaded engagement.

In this embodiment, the attachment fitting 500 further includes a shaft692 configured to pass through the opening 682 of the slot 680 and anexpanded distal portion 694. In one non-limiting example, the shaft 692may be a cylindrical element with a cylinder diameter that is slightlyless than the slot width SW. The attachment fitting 500 is retainedwithin the slot 680 due to the mechanical interference of the distalcontact surface 700 of the expanded distal portion 694, which protrudesdistally from the slot 680. In addition, the diameter of the proximalcontact surface 698 of the attachment fitting 500 is larger than theslot width SW to prevent the attachment fitting 500 from passing throughthe slot in a proximal direction.

In use, a rod 2096 or other element of a spinal stabilization system maybe inserted within the groove 690 and held in a fixed attachment withinthe groove 690 by tightening down the locking nut 696, thereby pressingthe rod 2096 against the lower surface 704 of the locking nut 696, thewalls of the groove 690, and the raised rim 684 of the slot 680. Inaddition, the tightening of the locking nut 696 presses the contactsurface 700 of the attachment fitting 500 against the distal surface 702of the slot 680, effectuating a locked mechanic engagement between theattachment fitting 500 and the attachment element 652. Furthermore, theouter surfaces of the attachment fitting 500 may be configured withtool-engaging and/or tool alignment features such that a tool (e.g., arod reducer tool) may reversibly couple to said features in anarrangement such that a longitudinal axis of a rod 2096 may be persuadedto align with a longitudinal axis of the groove 690 in a parallelmanner, and further the tool may guide and drive the rod 2096 intoengagement with the groove 690; additionally, the tool may be configuredto allow passage and alignment of the locking nut 696 through at least aportion of the tool while the tool provides the arrangement such thatwhen the locking nut 696 is distally displaced in or by the tool orparts thereof, the locking nut 696 may be accurately received bycorresponding locking nut engagement features of the attachment fitting500 (e.g., complementary threads).

In one embodiment, a spinal rod reducer tool may be used to place a rod2096 extending from a lumbar spine into or near the attachment fitting500. In another embodiment, a spinal rod (parallel) distractor may beused to distract a lumbar vertebra situated a distance from one or moreelements of the implant assembly 15. In this other embodiment, thelumbar vertebra may be distracted to restore a lost disc height betweenthe lumbar vertebra and an adjacent vertebra including, but not limitedto the L5-S1 disc height during a procedure to treat a medicalcondition. In an additional embodiment, a spinal rod (parallel)compressor may be used to compress and/or draw together certaincomponents of the implant assembly 15 and/or associated tissues. Forexample, the spinal rod compressor may be used to draw adjacent surfacesof an ilium and a sacrum toward one another during a procedure to treata medical condition.

In one embodiment, the contact surface 700 of the attachment fitting500, the distal surface 702 of the slot 680, and the proximal contactsurface 698 of the attachment fitting 500 may be essentially planarsurfaces. In other embodiments (not shown), these contact surfaces maybe curved in order to permit limited rotation about one or more axes tofacilitate the placement and alignment of the rod 2096 or other elementwithin the spinal support system.

Referring again to FIG. 12, the attachment fitting 500 may be providedin the form of a slideable socket 706 configured to attach in areversibly locked mechanical engagement with a guide 505 in the form ofa guide rail 708. FIG. 21 is an isometric view of the slideable socket706 in one embodiment. Referring to FIG. 21, the slideable socket 706may include at least two support elements 710 and 712 forming the sidesof at least one upward-opening groove 714. In this embodiment, theslideable socket 706 may further include a channel 716 configured toreceive the guide rail 708 in a sliding engagement. The proximal surfaceof the channel 716 may be formed by a slideable insert 718 configured topress on the proximal surface of the guide rail 708 to lock theslideable socket 706 onto the guide rail 708 in use.

FIG. 22 is a cross-sectional isometric view of the slideable socket 706in another embodiment. In this other embodiment, the slideable socket706 includes a distal element 720 and a proximal element 722. The distalelement 720 forms the lower channel surface 724 and side channelsurfaces 726. In addition, the distal element 720 includes a circularflange 728 that slideably engages a corresponding annular channel 730;this slideable engagement allows the proximal segment to rotate about acentral axis 790 of the proximal segment 722. This rotation permits therod 2096 or other element of a spinal stabilization system to be alignedalong a wide range of angles, as illustrated in FIGS. 15A-15C.

Referring again to FIG. 22, the proximal portion 722 of the slideablesocket 706 includes the at least two support elements 710 and 712 thatinclude a threaded inner surface 732 configured to receive a locking nut734 in a threaded engagement. Alternatively, the outer surface 795 maybe threaded and configured to receive a locking nut (not shown). Theproximal portion 722 further includes a slideable insert 736 configuredto slide proximally and distally within the essentially cylindricallumen formed by the at least two support elements 710 and 712. Theproximal surface 738 of the slideable insert 736 forms the bottomsurface of the groove 714 and the distal surface 740 of the slideableinsert 736 forms the proximal surface 718 of the channel 716 illustratedin FIG. 21.

FIG. 23 is a cross-sectional view of the slideable socket 706 mounted onthe guide rail 708 and engaging a rod 2096 of a spinal stabilizationsystem in a mechanically locked engagement. In use, the rod 2096 orother element of a spinal stabilization system may be inserted withinthe groove 714 formed by the proximal surface 738 of the slideableinsert 736 and held in a fixed attachment within the groove 714 bytightening down the locking nut 734, thereby pressing the rod 2096between the lower surface 744 of the locking nut 734 and the proximalsurface 738 of the slideable insert 736. As the locking nut 734 isadvanced into the slideable socket 706, the slideable insert 736 isshifted in a distal direction until the distal surface 740 of theslideable insert 736 contacts that proximal surface 746 of the guiderail 708. As the locking nut is further tightened, the guide rail 708 ispressed between the distal surface 740 of the slideable insert 736 andthe lower surface 724 of the channel 716, thereby mechanically lockingthe slideable socket 706 in a fixed engagement on the guide rail 708.

In one embodiment, the guide rail 708 may include an end stop 742 with across-sectional area that is larger than the cross-sectional area of thechannel 716 to prevent the slideable socket 706 from slipping off of theend of the guide rail 708 as illustrated in FIG. 23. In this embodiment,the guide rail 708 has a rectangular cross-sectional shape to preventthe slideable socket 706 from rotating about the longitudinal axis ofthe guide rail 708 as illustrated in FIG. 21. In general the guide railmay have any cross-sectional shape without limitation so long as thecross-sectional shape and dimensions of the channel 716 permit theinsertion of the guide rail 708 in a sliding engagement.

In another embodiment (not shown) the guide rail 708 may have a circularcross-sectional shape to permit the slideable socket 706 to rotate aboutthe longitudinal axis of the guide rail 708, thereby enhancing theability of the slideable socket 706 to position the rod 2096 of thespinal stabilization system into a desired position and orientation. Inthis other embodiment, as before, the slideable socket may be lockedinto place by tightening the locking nut 734 into the slideable socket706 as described herein previously.

In an additional embodiment, illustrated in FIG. 10D, the attachmentelement 652 may be provided in the form of a projection 708A projectingfrom the proximal end 45 of the insertion element 650. In thisembodiment, a rod 2096 of a spinal support system may be attached to theprojection 708A using a connector 706A. The projection 708A may have anycross-sectional profile without limitation. FIGS. 10E-10H illustratenon-limiting examples of suitable cross-sectional profiles of theprojection 708A taken at section C-C of FIG. 10D in various embodiments.

The connector 706A may be any suitable design known in the art. FIG. 10Kand FIG. 10L are cross-sectional diagrams taken at section G-G of FIG.10D. In this embodiment, the connector 706A may include a body 1008containing two or more channels 1090A and 1090B configured to house theprojection 708A and the rod 2096. The channels 1090A and 1090B may berelatively closed, as illustrated in FIG. 10K, or may be at leastpartially open, as illustrated in FIG. 10L. The body 1008 may furtherinclude two or more threaded fittings 1092A and 1092B each configured toreceive a set screw 1088A and 1088B. When the set screws are advancedinto the threaded fittings of the body 1008, the projection 708A and therod 2096 are retained by mechanical pressure between the set screws1088A and 1088B and the walls of the channels 1090A and 1090B.

FIG. 24 is a top view of an implant body 25 in an additional embodiment.In this additional embodiment, the guide rail 708 is divided into afixed segment 748 and a pivotable segment 750 mechanically attached in apivoting engagement including, but not limited to, a pin joint 752. Thepin joint 752 permits the free end 754 of the pivotable segment 750 torotate a pivot angle 13 within a predetermined range, thereby enhancingthe ability of the slideable socket 706 to position the rod 2096 (notshown) of the spinal stabilization system into a desired position andorientation. In this additional embodiment, the pin joint 752 may belocked to fix the pivot angle 13 at a desired position; non-limitingexamples of suitable locking mechanisms include a locking pin, a setscrew, and any other suitable hinge joint locking mechanism. In anotheradditional embodiment, the guide rail 708 of the implant body 25 mayinclude two or more pivotable segments 750.

In yet other embodiments, the implant body 25 may include two or moreslideable sockets 706 situated on the guide rail 708 of the attachmentelement 652. FIG. 25 is a top view of an implant body 25 in one otherembodiment. As illustrated in FIG. 25, the guide rail 708 may berelatively elongated to accommodate a first slideable socket 706A and asecond slideable socket 706B. In this other embodiment, the secondslideable socket 706B may be used to anchor a second element 2096B of aspinal stabilization system. In additional embodiments, these elementsmay be configured to connect at least two implants in a fixed orstabilized relation.

In various other embodiments, the attachment fitting 500 may be attachedin a fixed position to the attachment element 652 of the implant body25. In one aspect, illustrated in FIG. 43B, the attachment fitting maybe provided in the form of a tulip-like head 676 similar to the head ofthe polyaxial screw 678 described previously herein and illustrated inFIG. 18. In this embodiment, the head 676 is attached to a post 4302protruding proximally from the attachment element 652. In variousembodiments, the post 4302 may be fixed in position on the attachmentelement 652. In one aspect, the post 4302 may be situated between one ormore bores 40 and 40A through which one or more anchors 30 and 30A maybe inserted into the underlying bone tissue as described previouslyherein. The shape of the post 4302 may be spherical to accommodate apolyaxial head 676 as illustrated in FIG. 43B.

In another embodiment employing the polyaxial head 676, illustrated inFIGS. 99-131, the attachment element 650 and the insertion element 652may be configured to conform closely with the underlying bone tissue andsacroiliac joint space. Referring to FIG. 120, in this embodiment, theattachment element 652 may be formed into a curved shape to conform withthe surrounding bone tissue. In addition, the bores 40 and 40A whichguide anchors 30 and 30A into the underlying bone tissue may berelatively widely separated to enhance the stability of the implant body25 during use. Referring to FIGS. 128-130, the insertion element mayintersect the attachment element 652 at a non-perpendicular angle inorder to better conform with the bone tissue in the vicinity of thesacroiliac joint space. As illustrated in FIG. 116, the anchors 30/30Amay be advanced in a sideways and downward direction. In thisembodiment, the anchor 30 may be advanced laterally and downward throughthe sacrum 1004 and into the ilium 1005 and the anchor 30A may beadvanced in a medial downward direction into the sacrum 1004. FIG. 131is an exploded view of the various components depicted in FIGS. 99-130.

In another embodiment, illustrated in FIGS. 132-139, one of the anchors30 may be directed through a pair of bores 40 and 40B formed in theattachment element 652 and the insertion element 650, respectively. Thisarrangement of bores 40 and 40B result in a controlled and repeatableinsertion direction for the anchor 30.

The polyaxial head 676 is illustrated in greater detail in FIGS.140-152. Referring to FIG. 148, the polyaxial head 676 is mounted in anessentially spherical post 4302 that is affixed to the attachmentelement 652. The post may be provided with any profile withoutlimitation including spherical, cylindrical, or polygonal. The sphericalprofile permits a higher degree of freedom for the polyaxial head 676 torotate in any direction, which the other profile may increasinglyconstrain the possible movements of the polyaxial head to a narrowerrange of motion. Referring again to FIG. 148, the polyaxial head may beassembled by pushing the tine s 2620 of an insert 2610 over thespherical post 4302. The tines 2620 may be configured to deform slightlyto permit a snug fit of the insert over the post 4302. The polyaxialhead 676 may be slipped over the insert 2620 and a threaded compressionnut 2822 may be threaded into the polyaxial head 676 to compress a rod2096 inserted into the polyaxial head 676.

Referring to FIG. 147, as the threaded compression nut 2822 is advancedinto the polyaxial head 676, the rod 2096 is compressed between the post4302 and the threaded compression nut 2822, resulting in the fixation ofthe rod 2096 to the polyaxial head 676, as well the immobilization ofthe polyaxial head due to compression against the post 4302. FIGS.158-173 are various views of the sacroiliac joint and associatedskeletal structures of a patient illustrating the position andorientation of an implant assembly 15 with a polyaxial attachmentfitting illustrated in FIGS. 132-152 after completion of implantation.

In other embodiments, the post 4302 may be configured to attach to otherforms of attachment fittings, such as monoaxial heads as illustrated inFIGS. 153-157. The monoaxial head 500A is attached to the attachmentfitting 652 in a fixed position, thereby provided enhanced structuralstrength relative to similarly dimensioned polyaxial heads 676.Referring to FIG. 154, the monoaxial head included a threaded fittingconfigured to receive a threaded compression nut 2822 and to hold a rod2096 in a similar manner to the polyaxial head 676. However, themonoaxial head 500A does not permit rotational motion by virtue of itsfixed position on the attachment element 652. Referring to FIG. 157, inone embodiment, the monoaxial head 500A may be formed as a continuousstructure with the attachment fitting 652.

In another embodiment of an implant assembly, illustrated in FIGS.178-182 and FIGS. 191-212, the attachment fitting may be embodied as ahook-like attachment fitting 500B. Shown, for example, in FIGS. 206-208and FIG. 210, an implant body 25 of the implant assembly may include aninsertion element 650 to be inserted into a joint space of thesacroiliac joint, and an attachment element 652 at an angled orientationrelative to the insertion element 650, as described above. The angledescribed by the insertion element 650 and the attachment element 652may be greater than 90 degrees but less than or equal to 180 degrees inat least some embodiments. As generally shown in FIGS. 178-182 and FIGS.191-212, this angle may be approximately 120-130 degrees, although otherangles may be utilized in other embodiments. As with some of theexamples discussed above, the insertion element 652 may include one ormore fins 50 or other projections to enhance the grip of the insertionelement 650 within the joint space of the sacroiliac joint.

The attachment element 652 may include a first bore 40 and a second bore40A, through which a first anchor 30 and a second anchor (not shown),respectively, may be received to anchor the implant body 25 within thejoint space of the sacroiliac joint. The bore 40 may be formed (at leastin part) through a boss 41 defined on the attachment element 652. Theboss 41 may further comprise an external surface (or portion thereof)which is arranged such that it is aligned in a generally orsubstantially parallel relation relative to a longitudinal axis of bore40 and in a substantially transverse relation relative to anothersurface of attachment element 652 in proximity thereto (e.g., FIG. 205).The anchors may be, in one example, self-tapping bone screws with a headconfigured with a hexalobular internal or external drive type conformingto the ISO 10664 standard. In another example, as depicted in FIG. 195B,the anchor 30 may include machine threads at a proximal portion 43 ofthe anchor 30, wherein the threads are configured to receive a domed nut44 configured to apply force to an upper surface of the boss 41 whentightened sufficiently. In addition, the insertion body 650 may define athird bore 40B through which the first anchor 30 may extend. As shown inFIGS. 192 and 200A, for example, the first bore 40 and the third bore40B may be configured such that the first anchor 30 extends at an anglerelative to both the insertion element 650 and the attachment element652, thus facilitating extension of the first anchor 30 through thesacrum, and possibly transversely across the sacroiliac joint and intothe ilium. The second bore 40A may be configured such that the secondanchor is oriented perpendicularly to the attachment element 652.

In the embodiment illustrated in FIG. 200B, instead of a third bore 40B,the insertion element 650 may define a distal opening or slot 51extending distally from an area of the insertion element 650 near theattachment element 652, through the distal end of the insertion element650 and between two fins 50 extending substantially perpendicularly fromboth the medial and lateral sides of the insertion element 650. In oneexample, the first bore 40 may extend at an angle through both theattachment element 652 and the insertion element 650, including theintersection thereof, such that the first bore 40 and the distal openingor slot 51 are joined. Such a configuration is more apparent in FIG.200C. Moreover, as shown in the embodiment of FIG. 200C, the first bore40 may open laterally through the attachment element 652. Consequently,in this particular configuration, the anchor 30 may be installed intothe patient first, followed by the implant body 25, by sliding theimplant body 25 laterally onto the anchor 30 prior to final tighteningof the anchor 30. Additionally, other mechanisms may be utilized tocouple the anchor 30 to the implant body 25 in such an arrangement ofthe attachment element 652 having a lateral opening. For example, anadditional component (not shown) of the attachment element 652 mayreleasably couple with the attachment element 652 such that once theimplant body 25 is laterally slid onto the anchor 30, the additionalcomponent may be coupled with the attachment element 652 to secure theanchor 30 to the attachment element 652. Other numbers and orientationsof anchors, and their respective bores, openings, or slots, may beemployed in other embodiments.

Referring, for example, to FIGS. 205-208 and 210, the attachment element652 may further include a post protruding perpendicularly therefrom andincluding an at least partially threaded tip 4304 extending from a base4302 of the post. As shown in various views, the threaded tip 4304 isconfigured to receive the hook-like fitting 500B by way of a post bore4316 of the hook-like attachment fitting 500B, as shown in the isolationviews of FIG. 211. A threaded nut 4306 (see, e.g., FIG. 212) may then berotated onto the threaded tip 4304 to secure the hook-like fitting 500Bto the attachment element 652, as depicted at FIG. 192, for example.

More specifically, as shown, for example, in the isolation views of FIG.211, the hook-like attachment fitting 500B may include a hooked-shapedcollar 4308 with a curved underside 4314 configured to contact and wraparound a portion of the circumference of the rod 2096. Thus, prior totightening the threaded nut 4306 onto the threaded tip 4304 of the post,the hook-like attachment fitting 500B may rotate about a longitudinalaxis of the threaded tip 4304 while wrapping the rod 2096 to allowrepositioning of the rod 2096. Further, as depicted, for example, inFIG. 207 and in the cross-sectional view of FIG. 206, the post bore 4316(in part or in full) may be somewhat conical in shape, such that adiameter of the post bore 4316 may be larger near a top end of the postbore 4316 than at a bottom end of the post bore 4316 to facilitate somepivoting of the hook-like attachment fitting 500B relative to thelongitudinal axis of the threaded tip 4304 during repositioning of therod 2096. Also, the post base 4302 generally may be larger than the postbore 4316 and provide a rounded upper surface to facilitate the pivotingof the hook-like attachment fitting 500B atop the post base 4302. Inaddition, the hook-like attachment fitting 500B may include a roundedupper portion 4310 (see, e.g., FIG. 211) to contact a rounded underside4312 of the threaded nut 4306 (see, e.g., FIG. 212) to furtherfacilitate such pivoting.

Once a desired position for the rod 2096 has been achieved, the nut 4306may be further tightened onto the threaded tip 4304, pressing thehook-shaped collar 4308 against the rod 2096 and immobilizing the rod2096 between the curved underside 4314 of the hook-shaped collar 4308and the post base 4302 beneath the rod 2096, as shown in, for example,FIGS. 194, 195, 205, and 206. Consequently, secure attachment of the rod2096 at a variety of angles about a longitudinal axis of the post base4302 and the threaded tip 4304 is possible.

In yet another embodiment of an implant assembly, illustrated in FIGS.183-186 and 213-244, the attachment fitting may be embodied as apivoting clamp attachment fitting 500C. As shown with respect to theembodiment utilizing the hook-like attachment fitting 500B, an implantbody 25 of the implant assembly may include an insertion element 650 andan attachment element 652 at an angled orientation relative to theinsertion element 650, as described above. At least some of the variousfeatures of the implant body 25, such as the angle described by theinsertion element 650 and the attachment element 652, the fins 50, thefirst bore 40, the second bore 40A, and the third bore 40B, may be asdescribed above in conjunction with the embodiment of FIGS. 178-182 and191-212.

Referring, for example, to FIGS. 224-228, the attachment element 652 mayfurther include a post extending perpendicularly therefrom and includinga base 2838 and at least a partially threaded tip 2836 extendingtherefrom. The threaded tip 2836 may be configured to receive a threadednut 2840 for retaining an extension arm 2824 to which the pivoting clampattachment fitting 500C is to be attached. As shown, for example, inFIGS. 232-234, the extension arm 2824 may include a rounded portion 2834defining an elongated channel 2826, with the rounded portion 2834located at the end of a clamp section 2832 to which the pivoting clampattachment fitting 500C is to be attached. The elongated channel 2826may be configured to accept the threaded tip 2836 of the postessentially perpendicularly therethrough at any of a number of locationsalong the elongated channel 2826.

In reference to FIGS. 235-241, to securely attach the extension arm 2824to the attachment element 652, a collar 2842 (see, e.g., FIG. 239) mayrest atop the post base 2838. The collar 2842 may include a concave top2848 upon which a lower washer 2846 with a convex side may be placed tosupport the extension arm 2824. More specifically, the convex side ofthe lower washer 2846 may face the concave top 2848 of the collar 2842,and an opposing flat side of the lower washer 2846 may contact theextension arm 2824. Similarly, atop the extension arm 2824 may be placedan upper washer 2844, followed by the threaded nut 2840, with the upperwasher 2844 having a flat side contacting the extension arm 2824 and aconvex side configured to contact a concave underside 2850 of thethreaded nut 2840 (see, e.g., FIG. 241). Using such an arrangement,after orienting the extension arm 2824 to a desired angle about the postrelative to the attachment element 652, the threaded nut 2840 may betightened to urge the upper washer 2844, the extension arm 2824, thelower washer 2846, and the collar 2842 together against the post base2838 to securely immobilize the extension arm 2824 (see, e.g., FIG.235). In some examples, some amount of adjustment of the orientation ofthe extension arm 2824 from perpendicularity with the post may bepossible before tightening of the threaded nut 2840 due to the convexand concave surfaces of the components described above (see, e.g., thecross-sectional view of FIG. 226). This adjustment ability may befurther enhanced by way of a cross-section of the rounded portion 2834of the extension arm 2824 describing a convex surface facing theelongated channel 2826 (see, e.g., the cross-sectional views of FIGS.226 and 234).

The pivoting clamp attachment fitting 500C may be configured to securelycouple the rod 2096 to the attachment element 652 of the implant body 25via the extension arm 2824. As illustrated in FIGS. 230 and 231, thepivoting clamp attachment fitting 500C may generally possess the shapeof a rectangular prism and define a threaded hole 2852, a rod bore 2854,an extension bore 2856, and an internal spline area 2858 within theextension bore 2856. The extension bore 2856 may be generally circularin cross-section and configured to receive the clamp section 2832 of theextension arm 2824. Further, the clamp section 2832 may include a rodretention area 2828 (see, e.g., FIGS. 228, 229, and 232-234) such thatthe clamp section 2832 of the extension arm 2824 is to be inserted intothe extension bore 2856 such that the rod retention area 2828 alignswith the rod bore 2854, as depicted in FIGS. 242 and 244. The rod bore2854, as illustrated in the various views, may possess a cross-sectionof two overlapping circular areas, with a larger upper area and aslightly smaller lower area. Such a configuration may facilitateinsertion of the rod 2096 into the upper area of the rod bore 2854,followed by a driving of the rod 2096 into the lower area in response totightening a threaded compression nut 2822 into the threaded hole 2852of the pivoting clamp attachment fitting 500C (see, e.g., FIGS. 230 and235). Moreover, in one example, the extension arm 2824 may be insertedinto the extension bore 2856, with the rod retention area 2828 alignedwith the rod bore 2854, prior to insertion of the rod 2096 through therod bore 2854.

While the clamp section 2832 of the extension arm 2824 is installed inthe extension bore 2856, and the rod 2096 is installed within the rodbore 2854, the angle of the pivoting clamp attachment fitting 500C andthe rod 2096 relative to a longitudinal axis of the clamp section 2832may be adjusted slightly. The threaded compression nut 2822 may then beinserted into the threaded hole 2852 and tightened to urge the rod 2096against the clamp section 2832 of the extension arm 2824. In turn, asillustrated, for example, in FIGS. 224, 225, and 235, the clamp section2832 of the extension arm 2824 may be biased toward a lower wall of theextension bore 2856 of the pivoting clamp attachment fitting 500C, thussecuring the pivoting clamp attachment fitting 500C and the rod 2096 tothe extension arm 2824. To enhance the immobilization of the rod 2096,the extension arm 2824 may include an exterior spline area 2830 (see,e.g., FIG. 232) and the pivoting clamp attachment fitting 500C maydefine an interior spline area 2858 (see, e.g., FIGS. 230 and 231) that,when the clamp section 2832 of the extension arm 2824 is located withinthe extension bore 2856, as described above, the interior spline area2858 and the exterior spline area 2830 engage to resist rotation of thepivoting clamp attachment fitting 500C and the rod 2096 about alongitudinal axis of the clamp section 2832 of the extension arm 2824(see, e.g., FIG. 214). FIG. 224 provides a cross-sectional view of theextension arm 2824 and the rod 2096 prior to a complete tightening ofthe threaded compression nut 2822, and FIG. 225 presents across-sectional view of the extension arm 2822 and the rod 2096 afterthe complete tightening of the threaded compression nut 2822 to engagethe interior spline area 2858 with the exterior spline area 2830.

As a result of the use of the pivoting clamp attachment fitting 500C andassociated extension arm 2824, the rod 2096 may be securely coupled tothe attachment element 652 at a variety of radii from the threaded tip2836 of the post extending from the attachment element 652.

In another embodiment of an implant assembly, illustrated in FIGS.187-190 and 245-257, 258A, and 258B, the attachment fitting may beembodied as a vertically-sliding clamp attachment fitting 500D. As shownin conjunction with the embodiments utilizing the hook-like attachmentfitting 500B and the pivoting clamp attachment fitting 500C, an implantbody 25 of the implant assembly may include an insertion element 650 andan attachment element 652 at an angled orientation relative to theinsertion element 650, as described above. At least some of the variousfeatures of the implant body 25, such as the angle described by theinsertion element 650 and the attachment element 652, the fins 50, thefirst bore 40, the second bore 40A, and the third bore 40B, may be asdescribed above in conjunction with the embodiment of FIGS. 178-182,191-212, 183-186, and 213-244.

Referring, for example, to FIGS. 249-254, the vertically-sliding clampattachment fitting 500D may define an elongated channel 2870 throughwhich a threaded end 2862 of a receiving bolt 2860 may be inserted toattach the rod 2096 to the attachment element 652. Thevertically-sliding clamp attachment fitting 500D may extend generallyperpendicularly from the attachment element 652. In one example, thevertically-sliding clamp attachment fitting 500D may be rigidly fixed tothe attachment element 652, while in other embodiments, thevertically-sliding clamp attachment fitting 500D may be rotatablycoupled to the attachment element 652 about a longitudinal axis of thevertically-sliding clamp attachment fitting 500D to allow fixation ofthe rod 2096 to the attachment element 652 at any of a variety of anglesrelative to that longitudinal axis.

The receiving bolt 2860, as depicted in FIGS. 257 and 258A, may define arod bore 2868 through which an end of the rod 2096 may be received andsecured. In some examples, the receiving bolt 2860 may include an angledregion 2864 situated about a longitudinal axis of the receiving bolt2860 between the rod bore 2868 and the threaded end 2862. The angledregion 2864 may be configured such that the end of the angled region2864 closest to the rod bore 2868 is wider in diameter than the end ofthe angled region 2864 closest to the threaded end 2862. In someexamples, the angled region 2864 may form an exterior spline area toengage with a cooperating interior spline area 2872 facing the elongatedchannel 2870 of the vertically-sliding clamp attachment fitting 500D(see, e.g., FIG. 254). The receiving bolt 2860 may also define a planarcontraction space 2866 extending from the rod bore 2868 through thethreaded end 2862 (see, e.g., FIGS. 257 and 258).

To secure the rod 2096 to the attachment element 652, the rod 2096 maybe inserted into the rod bore 2868 of the receiving bolt 2860, and thethreaded end 2862 of the receiving bolt 2860 may be inserted into theelongated channel 2870 of the vertically-sliding clamp attachmentfitting 500D at a desired location along the elongated channel 2870.Further, the receiving bolt 2860 and the rod 2096 may be rotated withinthe elongated channel 2870 to a desired orientation. A threaded nut 2880(see, e.g., FIGS. 257 and 258A) may then be rotated onto the threadedend 2862 of the receiving bolt 2860 and tightened. As a result of thistightening, the angled region 2864 of the receiving bolt 2860 may bewithdrawn into the elongated channel 2870, thus shrinking a width of theplanar contraction space 2866 and compressing the rod bore 2868 tosecure the rod 2096 within the receiving bolt 2860 (see, e.g., FIGS.246, 248, 253, and 254). In addition, if the angled region 2864 of thereceiving bolt 2860 forms an exterior spline structure and the elongatedchannel 2870 defines the interior spline area 2872, as mentioned above,the exterior spline area and the interior spline area 2872 may engage toresist rotation of the receiving bolt 2860 within the elongated channel2870.

FIG. 258B illustrates another example of the receiving bolt 2860. Inthis embodiment, instead of employing a planar contraction space 2866extending from the rod bore 2868 through the threaded end 2862, aspreviously exhibited in FIG. 258A, the receiving bolt 2860 may include acontraction space 2866A that extends from within the threaded end 2862completely through an open rod bore 2868A, thus forming two arms 2869.As a result of the tightening of the receiving bolt 2860 in thisexample, the angled region 2864 of the receiving bolt 2860 may bewithdrawn into the elongated channel 2870, thus shrinking thecontraction space 2866A and urging the arms 2869 of the open rod bore2868A toward each other to secure the rod 2096 within the receiving bolt2860.

Based upon the use of the vertically-sliding clamp attachment fitting500D and related components, as discussed above, the rod 2096 may besecurely coupled with the attachment element 652 at a variety ofdistances from the attachment element 652 and at a number of anglesrelative to an axis perpendicular to the longitudinal axis of thevertically-sliding clamp attachment fitting 500D.

iii. Anti-Migration Features on Bone Contact Surfaces

In various embodiments, the implant body 25 may further include surfacefeatures and/or textures on any exposed surface making contact withunderlying bone tissue. These surface features may interact with thebone tissue within the sacroiliac joint space mechanically and/orbiologically and may include anti-migration surface features. Theseanti-migration surface features may assist in preventing the insertionplate 45 from loosening, moving, and/or or migrating within theafflicted area during prolonged use by the patient. Non-limitingexamples of exposed surfaces of the implant body 25 making contact withunderlying bone tissue include: the insertion plate 45 including themedial face 654, the lateral face 656, the edges 658, and/or the one ormore fins 50; the attachment element 652 including the distal surface.Non-limiting examples of anti-migration surface features include aplurality of projections, a plurality of serrated teeth or ridges, aplurality of perforations, or any other surface feature which may reducethe migration of insertion plate 45 and/or implant body 25.

The surface features may be unidirectional in one embodiment. FIG. 26 isa bottom isometric view of an insertion plate 45 of an implant body 25with anti-migration surface features 355 included on the exposedsurfaces of the insertion plate 45 of the implant body 25. As shown inFIG. 26, the anti-migration features 355 are generally evenlydistributed along the medial face 654, the lateral face 656 (not shown),and each of the fins 50 in a rows and columns arrangement. Theanti-migration features 355 are generally similarly distributed alongthe planar surfaces of the edges of the fins 50. The anti-migrationfeatures 355 may be in the form of trapezoids, squares, rectangles, etc.The anti-migration features 355 may have a rectangular cross sectionalelevation with a thickness ranging from approximately 0.2 mm toapproximately 5 mm. In another aspect, illustrated in FIG. 7A, theanti-migration surface features 355 may be generally evenly distributedalong a distal face 357 of the attachment element 652. In this otheraspect, the distal face 357 contacts the underlying bone tissue once theimplant assembly 25 is inserted within the joint space of the sacroiliacjoint.

As another example, as shown in FIG. 27 which is a front isometric viewof an insertion plate 45 of an implant body 25 with another type ofanti-migration surface features 355 included on the exposed surfaces ofthe insertion plate 45. As shown in FIG. 27, the anti-migration features355 are in the form of unidirectional serrated teeth or ridges 355,wherein the ridges 355 have a triangular cross sectional elevationwherein the rearward or trailing end of the features 355 are thetruncated or vertical end of the triangle cross sectional elevation, andthe front or leading end of the features 355 are the point end of thetriangle cross sectional elevation. The anti-migration features 355 withthe triangular cross sectional elevations have a thickness ranging fromapproximately 0.2 mm and approximately 5 mm, with one embodiment havinga thickness FT of approximately 1 mm to approximately 15 mm. Thetriangular ridges 355 may be generally evenly distributed along the fins50 in ridges that run transverse to the length of the insertion plate45. The anti-migration features 355 are generally similarly distributedalong the planar surfaces of the edges of the fins 50.

Although the anti-migration features 355 are depicted in the form ofunidirectional serrated teeth or ridges 355 on each of the texturedsurfaces of the insertion plate 45 in this embodiment, the invention isnot so limited and, as to particular embodiments, can be configured tohave said features 355 arranged in multiple directions, unidirectional,or a combination of multiple direction on some surfaces of the insertionplate 45 and unidirectional on other surfaces of the insertion plate 45.Accordingly, the features 355 can be so arranged on the various surfacesof the insertion plate 45 so as to prevent undesired migration inparticular directions due to the forces present at the sacroiliac joint1000.

In another embodiment, illustrated in FIG. 8D, the anti-migrationfeatures 355 may include one or more discrete projections 358. Asillustrated in FIG. 8D, the discrete projections 358 may project in adirection toward the underlying bone and may further enhance theanti-migration features 355 of the implant assembly 25. In one aspect,the discrete projections 358 may be in the form of a taperedperpendicular projection from a contact surface including, but notlimited to, the tapered discrete projection 358 projecting distally fromthe distal face 357 of the attachment element 652 as illustrated in FIG.8D.

Depending on the embodiment, the insertion plate 45 may have an edgeconfiguration of the fins 50 designed to prevent migration of theimplant body 25 once implanted in the sacroiliac joint space. Forexample, as shown in FIG. 28A which is a front isometric of an insertionplate 45 of an implant body 25, the anti-migration edges 360 of the fins50 are in the form of notches 365 generally evenly distributed alonglongitudinally extending free edges or ends of the fins 50. As indicatedin FIG. 28B, a rotated side view of the insertion plate 45 illustratedin FIG. 28A, the notches 365 may have parallel sides 370 inwardlyterminating as an arcuate end 375. The orientation of each notch 365 maybe such that the center line NL of the notch 365 forms an angle NA withthe center axis CA of the insertion plate 45 that ranges betweenapproximately 90 degrees and approximately 15 degrees. As indicated inFIG. 28, each notch 365 may have a length LN between the extreme pointon the arcuate end 375 and the outer edge boundary of the notch ofbetween approximately 0.2 mm and approximately 10 mm. Each notch 365 mayhave a width WN of between approximately 0.5 mm and approximately 20 mm.

As another example, as shown in FIG. 29 which is a front isometric of aninsertion plate 45 of an implant body 25, the anti-migration edges 360are flared longitudinally extending free edges or ends of the fins 50.The edges 360 include a series of ridges 370 that are generally evenlydistributed along the length of the edges 360 and oriented transverse tothe length of the edges 360.

As indicated in FIG. 29, the ridges 370 have triangular cross sectionalelevations with an overall height of between approximately 0.2 mm andapproximately 8 mm. As illustrated in FIG. 29, the flared longitudinallyextending free edges or ends of the fins 50 have rim edges 380 definingthe edges of the anti-migration edges 360 of the fins 50, wherein therim edges 380 have slopes 385 transitioning between the planar surfaces65 of the fins 50 and the rim edges 380.

The edges 360 have a height EH between the edges 380 of betweenapproximately 0.5 mm and approximately 15 mm, with one embodiment havinga height EH of approximately 4 mm. The width EW of the flared edge 360from the beginning of the sloped transition 385 to the face of the edge360 is between approximately 0.2 mm and approximately 9 mm, with oneembodiment having a width EW of approximately 1 mm.

In particular embodiments, the insertion plates 45 of the implant bodies25 with features as described above with respect to FIGS. 26-29 canalternatively be configured to function as a broach or other surgicalsite preparation tool that can assist in the removal of certain tissues,for example, cartilage or bone, during certain steps of a procedure. Incertain aspects, the implant body 25 may be configured as a trial toallow a surgeon presented with a number of different embodiments ofimplant bodies 25 to evaluate the different embodiments to assess thesuitability of any particular embodiment for the treatment of aparticular patient, an idiopathic anatomy, a particular implantreceiving space and/or other application.

In one additional aspect, the exposed surfaces of the implant body 25making contact with underlying bone tissue may be treated with a bonegrowth factor or other compounds to encourage bone tissue growth aroundthe implant assembly 200.

Non-limiting examples of exposed surfaces of the implant body 25 makingcontact with underlying bone tissue include: the insertion element 650including the medial face 654, the lateral face 656, the edges 658,and/or the one or more fins 50; the attachment element 652 including thedistal surface.

II. Delivery Tool

To begin a detailed discussion of components of an embodiment of thedelivery tool 20, reference is again made to FIGS. 1 and 2. As shown inFIG. 2, the delivery tool 20 includes a distal end 35 and a proximal end80. The distal end 35 supports the implant assembly 15 componentsincluding, but not limited to, the implant body 25. The proximal end 80is configured to be grasped and manipulated to facilitate theimplantation of the implant assembly 15 in the sacroiliac joint.

The delivery tool 20 further includes an arm assembly 85 made up of animplant arm 110 configured to retain the implant body 25 and an anchorarm 115 supported off of the implant arm 110 at a predetermined angle byan anchor arm fitting 112. In this embodiment, the delivery tool 20 mayfurther include a handle 90.

According to particular embodiments, the systems, delivery tools orparts thereof, for example, may be configured such as those described inU.S. patent application Ser. No. 14/567,956, filed Dec. 11, 2014,entitled “Implants, Systems, and Methods For Fusing a Sacroiliac Joint,”which is incorporated herein by reference in its entirety. Such a systemor parts thereof may allow placement of an anchor 30, e.g., through asacrum, across a sacroiliac joint, and into an ilium in a desiredposition and then subsequently allow placement of an insertion element650 in proximity to the anchor 30.

a. Implant Arm and Locking Screw

FIG. 35 is an exploded isometric view of the delivery tool 20illustrated previously in FIGS. 1 and 2. As illustrated in FIG. 35, thedelivery tool 20 further includes an arm assembly 85, a handle 90, alocking screw 95, a sleeve 100 and a trocar or guidewire 105. Theimplant body 25 may be reversibly attached to the distal end 35 of thedelivery tool 20 by inserting the locking screw 95 into the attachmentbore 70 within the implant body 25 in one embodiment. FIG. 36 is abottom isometric view of the distal end 35 of the delivery tool 20 inone embodiment. The locking screw 95 may be inserted through a bore 97formed through the distal end 35 such that a distal tip 96 of thelocking screw 95 may protrude from a planar extreme distal face 152 ofthe delivery tool 20. The locking screw 95 and attachment bore 70 may beprovided with meshing threads to enable a reversibly locked engagementwhen the distal tip 96 of the locking screw 95 is advanced into theattachment bore 70.

In various embodiments, the attachment bore 70 and locking screw 95 areessentially aligned with the implant arm 110 as well as the direction ofinsertion of the insertion element 650 of the implant body 25, asillustrated in FIG. 36 and FIG. 37. In addition, the attachment bore 70and locking screw 95 may be situated well away from the bore 40 withinthe attachment element 652. Without being limited to any particulartheory, the arrangement reduces the potential for mechanicalinterference of the locking screw 95 with the other fasteners such as ananchor 30, associated implant assembly tools, and/or any other surgicalinstruments involved in implanting the implant body 25 within the jointspace of a sacroiliac joint.

FIG. 39A is a bottom isometric view of a delivery tool 20 in a secondembodiment. In this second embodiment, the arm assembly 85 includes acannulated implant arm 110. In this embodiment, a first anchor arm 115Amay supported off of the implant arm 110 at first and secondpredetermined angles by a first anchor arm fitting 112A and secondanchor arm fitting 112B, respectively.

FIG. 40 is a distal isometric view of the arm assembly 85 in oneembodiment in which the anchor arms 115A/115B and anchor arm fittings112A/112B have been removed for better visualization. In tone or hisembodiment, the distal end 120 includes a cylindrical opening 137 of acylindrical bore 132, one or more fins 140/145, pins 150, and a planarextreme distal face 152. As depicted in FIG. 41, which is a longitudinalcross section of the implant arm 110 as taken along section line 20-20in FIG. 40, the cylindrical bore 132 extends the full length of theimplant arm 110 between the proximal opening 135 and the distal opening137.

As illustrated in FIG. 42, which is a full isometric view of an implantretainer 95, the implant retainer 95 includes a longitudinal cylindricalmember 210, a handle 215 on a proximal end 216 of the longitudinalcylindrical member 210, and a threaded implant retaining screw 220 on adistal end 218 of the longitudinal cylindrical member 210. As can beunderstood from FIGS. 9 and 39A-42, when the system 10 is assembled forthe delivery of the implant assembly 15 to the sacroiliac joint, thelongitudinal cylindrical member 210 extending from the handle 215 (seeFIG. 42) and implant arm bore 132 (see FIG. 41) such that a distal sideof the handle 215 abuts or nearly abuts with the implant arm proximalend 125 (see FIG. 41) and the threaded implant retaining screw 220 isreceived in the implant attachment bore 70 (see FIG. 9). In oneembodiment, the implant retaining screw 220 is in the form of a threadedshaft for engaging complementary threads in the attachment bore 70 ofthe implant body 25, thereby securing the implant proximal face againstthe implant arm distal face. In other embodiments, the implant retainingscrew 220 and the attachment bore 70 are configured so as to form aninterference fit between the two such that an intentional separatingforce is required to remove the implant engagement feature from withinthe attachment bore 70 and allow the release of the implant body 25 fromthe distal end 120 of the implant arm 110.

b. Alignment Pegs

Referring again to FIG. 36, the extreme distal face 152 has anessentially planar surface contour in order to match the essentiallyplanar surface contour of the implant body 25, particularly in theregion surrounding the attachment bore 70 in various aspects. Inaddition, the distal face 152 may include additional alignment featuresincluding, but not limited to, one or more alignment pegs 150. Thesealignment pegs 150 may mechanically interlock with correspondingfeatures on the implant body including, but not limited to, pegreceptacles, and notches.

In one embodiment, the alignment pegs 150 may be arranged in a patternmatched to an edge contour of the proximal end 43 of the insertionelement 650 of the implant body 25. FIG. 37 is a bottom isometric viewillustrating the implant body 25 mounted to the distal end 35 of thedelivery tool 20 illustrated in FIG. 36. In one embodiment, the lockingscrew 95 has been advanced and tightened into the attachment bore 70,thereby securing the proximal end 43 of the insertion element 650against the distal face 152 of the delivery tool 20. The one or morealignment pegs 150 closely fit the edge contour of the proximal end 43,thereby providing alignment mechanisms and resistance against twistingof the implant body 25 relative to the delivery tool 20.

In another embodiment, the proximal end 43 of the implant body 25 mayinclude one or more recesses 154 formed in the exterior surface of theimplant body 25 to receive one or more alignment pegs 150 protrudingdistally from the distal face 152 of the delivery tool 20. Referringback to FIG. 12, one or more recesses 154 may be provided to receive theone or more alignment pegs 150 (not shown). In one aspect, the one ormore recesses 154 may extend distally from the surface of the attachmentelement 652 for a distance DE ranging between about 0.2 mm and about 20mm. According to particular embodiments, the recess 154 can extend fromsaid exterior surfaces in the general direction of the attachment bore70 a distance DA ranging between about 0.25 mm to about 5 mm. In anon-limiting example of a particular embodiment, the distal face 152 ofthe implant arm distal end 35 can be further configured to wrapcompletely or only a portion of the periphery of the proximal end 43 ofthe implant body 25.

In an additional embodiment, the surface of the implant body 25contacting the distal face 152 of the delivery tool 20 may furthercontain one or more lateral bores 75 configured to receive one or morealignment pegs 150 protruding distally from the distal face 152 of thedelivery tool 20. Referring back to FIG. 9, the pegs 150 (not shown)being received in the lateral bores 75 prevent the implant body 25 frompivoting relative to the distal face 152 of the delivery tool 20. Thepegs 150 can be configured to have a rectangular, circular or any othercross section and the corresponding lateral bores 75 can also beconfigured to have corresponding shapes in cross section.

c. Anchor Arms

Referring again to FIGS. 1, 2, and 35, the arm assembly 85 includes animplant arm 110 and an anchor arm 115 supported off of the implant arm110 at a predetermined angle by an anchor arm fitting 112. The anchorarm fitting 112 may be mechanically attached to the implant arm 110 andmay include a bore 113. The anchor arm 115 may be mounted by situatingthe tines 116 projecting from the anchor arm on either side of theanchor arm fitting such that the fastener holes 117 formed within thetines 116 are aligned with the bore 113. The shaft 118 of the handscrew119 may by inserted through the aligned fastener holes 117 and bore 113to lock the anchor arm 115 in place. FIG. 38 is a top view of the anchorarm 115 mounted to the anchor arm fitting 112 on the implant arm 110 andsecured in place by the handscrew 119. In one embodiment, the shaft 118of the handscrew 119 may be threaded, and one or more of the fastenerholes 117 and/or bore 113 may be provided with corresponding matchingthreads. In other embodiments, the shaft 118 of the handscrew 119 may beprovided in the form of a retaining pin or any other reversibly lockingalignment device.

As shown in FIGS. 1, 2, and 35, the anchor arm 115 is supported off ofthe implant arm 110 at an angle and includes a proximal end 155 and adistal end 160 distally terminating in a sleeve or collar 165 having alongitudinal center axis LCA₁ that is generally transverse to thelongitudinal axis of the anchor arm 115. The collar 165 has a length ofbetween approximately 10 mm and approximately 60 mm (e.g., 20 mm)disposed between collar ends 166 and 167 configured to permit andmaintain accurate alignment of the first sleeve 100 along LCA₁ duringthe course of the procedure. The targeting proximal end 155 intersectsthe implant arm 110 at a location between the proximal and distal endsof the implant arm 110. In one embodiment, the proximal end 155 of theanchor arm 115 intersects proximal end 80 of implant arm 110. In anotherembodiment, the proximal end 155 of the anchor arm 115 is coupled toand/or supported off of the handle 90. Referring back to FIG. 39A, thearm assembly 85 of the delivery tool 20 may include a first anchor arm115A and second anchor arm 115B in another embodiment.

In various embodiments, each of the one or more anchor arms 115 areconfigured to guide one or more fasteners including, but not limited tothe anchor 30 (see FIGS. 2 and 15) and the polyaxial screw 678 (see FIG.9). In an embodiment, the anchor arm 115 may align the fastener alongthe direction LCA₁ (see FIG. 35) during insertion of the fastener. FIG.43A is a side cross-sectional view of the implant body 25 attached tothe delivery tool 20 in the embodiment illustrated previously in FIG.39A. As shown in FIG. 39A, the anchor 30 may be guided through the firstanchor arm 115A and the polyaxial screw 678 may be guided through thesecond anchor arm 115B.

In this embodiment, the first anchor arm 115A may have a sleeve 165Athat is relatively narrow and of constant cross-sectional profile. As aresult, the direction of insertion of the anchor 30 from the firstanchor arm falls within a relatively narrow range. The second anchor arm115B may have a conical sleeve 165B that permits the insertion of thepolyaxial screw 678 along a range of insertion angles constrained by thecontour of the conical sleeve 165B. The conical sleeve may be includedin the delivery device 20 to facilitate the placement and insertion offasteners in which some latitude in placement may be desired.

For example, the incorporation of a second anchor arm 115B with aconical sleeve 165B may permit a surgeon to select a desired insertiontrajectory for the anchor 30 while still passing the anchor 30 through,for example, a bore 40 and/or additional bore 670. Non-limitingcharacteristics of a desired trajectory of the anchor may include one ormore of: 1) entering at or near a S1 pedicle and further advanced in ananteromedial direction, and further toward or into sacral promontoryand/or parallel to an S1 endplate; 2) entering the bone structure nearor immediately adjacent a S1 or S2 foramen, and in a generallymediolateral direction further advanced to cross a sacroiliac joint, andfurther advanced to terminate in or through an ilium (e.g., along amidline between an inner and outer iliac wing table); or 3) be advanceddown the plane of a sacroiliac joint.

Referring back to FIG. 35, the longitudinal center axis LCA₁ of thetargeting collar 165 forms an angle A_(LCA1-LCA2) with the longitudinalcenter axis LCA₂ of the implant arm 110. For example, the angleA_(LCA1-LCA2) may be range between approximately 15 degrees andapproximately 135 degrees. As can be understood from FIG. 39A, in oneembodiment, the above-described coaxial and angular relationshipsbetween the anchor arm 115 and the implant arm 110 are rigidlymaintained due to the anchor arm 115 and its anchor arm fitting 112being in a fixed, non-adjustable configuration, and the interconnectionbetween the proximal end of the targeting 115 and the implant arm 110being a fixed, non-adjustable configuration at least with respect to theangle A_(LCA1-LCA2) between the longitudinal center axis LCA₁ of thetargeting collar 165 and the longitudinal center axis LCA₂ of theimplant arm 110. Thus, in one embodiment, the delivery tool 20 comesfrom the manufacture to the physician in a fixed, non-adjustableconfiguration having the coaxial and angular relationships articulatedabove with respect to FIG. 21A.

Referring to FIG. 35, the anchor arm 115 coaxial and angularrelationships between the anchor arm 115 and the implant arm 110 may beadjustable in another embodiment. In this other embodiment, the anchorarm fitting 112 may be translated in a proximal or distal directionalong the implant arm 110. In addition, the angle of the axis LCA1 maybe adjusted by rotating the anchor arm 115 about the shaft 118 of thehandscrew 119. The angle of the axis LCA1 may be maintained by lockingthe anchor arm 115 in place by tightening the handscrew 119.

III. Surgical Preparation Tools

As is discussed in greater detail below, some preparation of the jointspace of the sacroiliac joint, such as the removal of some cartilage orbone material therefrom, may be performed prior to the delivery andimplantation of the implant system into the joint space. As a result,one or more surgical preparation tools, such as various drills, cuttingtools, trial tool assemblies, and the like, may be employed, such asthose described in U.S. patent application Ser. No. 14/514,221, filedOct. 15, 2014, titled “Systems for and Methods of Preparing a SacroiliacJoint for Fusion,” which is incorporated herein by reference in itsentirety. For example, FIG. 259 provides an isometric side view of ajoint preparation tool assembly 2300 that is configured to test-fit animplant size and make a transverse cut into either or both the sacrumand ilium to make way for a fin or keel of an implant that is configuredto extend into the bone. As seen in that figure, the joint preparationtool assembly 2300 includes a trial tool assembly 2302 and a cuttingtool 2304 that is configured to translate relative to the trial toolassembly 2302 in order to make the transverse fin-cuts or keel-cuts intothe patient's bone.

The trial tool assembly 2302 includes an implant trial 2306 at a distalend 2308 of the assembly 2302. The implant trial 2306 is a planar memberwith a tapered tip 2310 that includes a width 2312 that corresponds witha width of an implant that may be subsequently delivered into a joint.The implant trial 2306 may be removably coupled with a shaft 2314 thatextends proximally. The shaft 2314 is removably attached to a handleassembly 2316 at a proximal end 2318 of the shaft 2314. The handleassembly 2316 includes a coupler 2320 configured to removably attach tothe shaft 2314 of the trial tool assembly 2302. The coupler 2320 isattached to a handle shaft 2410 that extends to a gripping handle 2322.

The implant trial 2306 is used to gauge the size of the joint space sothat an implant size may be chosen that best fits the joint space. Thus,the system described herein may include implant trials 2306 of varioussizes and configurations in order to gauge the size of the joint space.In operation, a surgeon may begin a surgical procedure by test-fittingthe smallest size of implant trial 2306 into the patient's joint todetermine the fit. If the size of the implant trial 2306 is too small,then the surgeon may remove the implant trial 2306 and deliver a largersize implant trial 2306 into the joint. Once an appropriate size ofimplant trial 2306 is received within the joint, the surgeon may use thecutting tool 2304 to deliver transverse keel-cuts into the boneysurfaces in preparation for the implant delivery.

The cutting tool 2304 is slidably coupled to the shaft 2314 of the trialtool assembly 2302 and configured to slide distal-proximal on the shaft2314. The cutting tool 2304 is slidably coupled to the shaft 2314 via adistal and a proximal collar 2324 that extend around the shaft 2314 ofthe trial tool assembly 2302. The collars 2324 are separated by a gapand are attached to a cutting tool shaft 2326 that extends proximally.The cutting tool shaft 2326 includes a curved mid-portion 2328 such thatthe shaft 2326 angles away from the shaft 2314 of the trial toolassembly 2302. A proximal end 2330 of the cutting tool shaft 2326includes an impact plate 2332 that is configured for being hit with ahammer or similar device to drive the cutting tool 2304 distally. Inthis way, the surgeon may securely hold the handle 2322 of the trialtool assembly 2302 with one hand and strike the impact plate 2332 withthe other hand.

Reference is now made to FIG. 260, which is an isometric view of anopposite side of the joint preparation tool assembly 2300. As seen inthe figure, a distal end 2334 of the cutting tool 2304 includes acutting element 2336 that extends within a guide 2338 formed in a topsurface 2340 to the tapered tip 2310 of the implant trial 2306 when thecutting element 2336 translates relative to the implant trial 2306. Adistal tip 2344 of the cutting element extends to the tapered tip 2310of the implant trial 2306 when the shaft 2326 of the cutting tool 2304abuts a proximal end 2346 of the implant trial 2306. The cutting tool2304 is configured to maintain an orientation relative to the guide 2338when the cutting element 2336 is proximally retracted or distallyextended towards the guide 2338 via a channel 2342 formed in the shaft2314 of the trial tool assembly 2302.

The possible use of the joint preparation tool assembly 2300 isdescribed below in conjunction with FIGS. 261A-261D as part of a methodin which an implant system 15 is implanted into the joint space of thesacroiliac joint using an intra-articular approach, as illustrated inFIGS. 47A-47P. However, the joint preparation tool assembly may also beutilized in connection with an extra-articular approach, as depicted inFIGS. 60A-60P, and as described below.

IV. Method of Use

In various embodiments, a method of implanting the implant system 15non-transversely into the joint space of the sacroiliac joint isprovided. The method includes preparing an implant insertion spacewithin the joint space, inserting the insertion plate 45 of the implantbody 25 into the implant insertion space using the delivery tool 20, andinserting an anchor 30 through a bore 40 within the implant body 25 tofix the implant body 25 in place using the delivery tool 20. A detaileddescription of the anatomical landmarks associated with the method, aswell as a description of the various stages of the method, includinginsertion space preparation, insertion of the insertion plate into thejoint space, and anchoring of the implant is provided in detail hereinbelow. The implant body 25 may be inserted via the extra-articularrecess of the sacroiliac joint in an extra-articular approach in oneembodiment. In another embodiment, the implant body 25 may be insertedvia interarticular region 1044 in an interarticular approach.

a. Anatomical Landmarks

To begin a discussion regarding the methodology associated withemploying any of the above-described delivery tools 20 in implanting anyof the above-described implant bodies 25 in the sacroiliac joint 1000 ofa patient 1001, reference is first made to FIGS. 44A-46B to identify thebone landmarks adjacent, and defining, the sacroiliac joint 1000. FIG.44A is a right lateral side view of a hip region 1002 of a patient 1001lying prone, wherein the soft tissue 1003 surrounding the skeletalstructure 1006 of the patient 1001 is shown in dashed lines. FIG. 44B isan enlarged view of the hip region 1002 of FIG. 44A. As illustrated inFIGS. 44A and 44B, a lateral view of the patient's hip region 1002reveals certain features of the ilium 1005, including the anteriorsuperior iliac spine 2000, the iliac crest 2002, the posterior superioriliac spine (PSIS) 2004, the posterior inferior iliac spine (PIIS) 2006,the greater sciatic notch 2008 extending from the posterior inferioriliac spine 2006 to the ischial spine 2010, and the tubercle of iliaccrest 2012. The sacroiliac joint articular region 1044 is shown indashed lines. A posterior inferior access region 2016 of the sacroiliacjoint articular region 1044 has a superior end 2018 on the sacroiliacjoint line 2019 that is between approximately 0 mm and approximately 40mm inferior the posterior inferior overhang 2020 of the posteriorsuperior iliac spine 2004. The posterior inferior access region 2016 ofthe sacroiliac joint articular region 1044 has an inferior end 2022 onthe sacroiliac joint line that is at approximately the intersection ofthe posterior inferior iliac spine 2006 with the lateral anterior curvedboundary 2024 of the sacrum 1004. In other words, the posterior inferioraccess region 2016 of the sacroiliac joint articular region 1044 has aninferior end 2022 on the sacroiliac joint line that is at approximatelythe superior beginning of the greater sciatic notch 2008.

FIG. 45A is a lateral-posterior view of the hip region 1002 of thepatient 1001 of FIG. 44A, wherein the patient 1001 is lying prone andthe soft tissue 1003 surrounding the skeletal structure 1006 of thepatient 1001 is shown in dashed lines. FIG. 45B is an enlarged view ofthe hip region 1002 of FIG. 45A. As shown in FIGS. 45A and 45B, alateral-posterior view of the patient's hip region 1002 reveals the samefeatures of the sacrum 1004 and ilium 1005 as discussed above withrespect to FIGS. 44A and 44B, except from another vantage point. Thevantage point provided via FIGS. 45A and 45B provides furtherunderstanding regarding the posterior inferior access region 2016 of thesacroiliac joint articular region 1044 and superior end 2018 andinferior end 2022 of the posterior inferior access region 2016 relativeto nearby anatomical features, such as, for example, the posteriorinferior overhang 2020 of the posterior superior iliac spine 2004, theintersection of the posterior inferior iliac spine 2006 with the lateralanterior curved boundary 2024 of the sacrum 1004, and the superiorbeginning of the greater sciatic notch 2008.

FIG. 46A is a posterior view of the hip region 1002 of the patient 1001of FIG. 44A, wherein the patient 1001 is lying prone and the soft tissue1003 surrounding the skeletal structure 1006 of the patient 1001 isshown in dashed lines. FIG. 46B is an enlarged view of the hip region1002 of FIG. 46A. As shown in FIGS. 46A and 46B, a posterior view of thepatient's hip region 1002 reveals the same features of the sacrum 1004and ilium 1005 as discussed above with respect to FIGS. 44A and 44B,except from yet another vantage point. The vantage point provided viaFIGS. 46A and 46B provides yet further understanding regarding theposterior inferior access region 2016 of the sacroiliac joint articularregion 1044 and superior end 2018 and inferior end 2022 of the posteriorinferior access region 2016 relative to nearby anatomical features, suchas, for example, the posterior inferior overhang 2020 of the posteriorsuperior iliac spine 2004, the intersection of the posterior inferioriliac spine 2006 with the lateral anterior curved boundary 2024 of thesacrum 1004, and the superior beginning of the greater sciatic notch2008. In addition, FIGS. 46A and 46B provide a view of the sacralpromontory 6002, the S1 superior articular process or S1 facet joint6004, and sacral ala 6006.

a. Implantation Via Extra-Articular Approach

i. Preparation of Implant Receiving Space

Now that the relevant anatomical landmarks have been identified withrespect to FIGS. 44A-46B, the methodology associated with employing anyof the above-described delivery tools 20 in implanting any of theabove-described implant bodies 25 in the sacroiliac joint 1000 of apatient 1001 can be discussed. In doing so, reference will be made toFIGS. 60A-60P, which are each a step in the methodology and illustratedas the same transverse cross section taken in along a plane extendingmedial-lateral and ventral dorsal along section line 101-101 in FIG.46B. In this cross section, the anterior portion of the articularsurfaces 1016 are covered by a thick layer of articular cartilage with ajoint space existing between them while the dorsal or posterior portionof the articular surfaces in this cross section are covered byligaments. FIGS. 60A-60P are simplified for illustrative purposes and donot show these features to scale. Now referring primarily to FIG. 60A,an embodiment of the method can include the step of placing a patientunder sedation prone on a translucent operating table (or other suitablesurface). The sacroiliac joint 1000 can be locally anesthetized to allowfor injecting a radiographic contrast 1046 (as a non-limiting example,ISOVIEW 300 radiographic contrast) under fluoroscopic guidance into theextra-articular space 3007 of the sacroiliac joint 1000 via theextra-articular recess access region 6000 to outline the articularsurfaces 1016 of the sacroiliac joint 1000) defined between the sacrum1004 and ilium 1005. Injection of the radiographic contrast 1046 withinthe sacroiliac joint 1000 can be accomplished utilizing a tubular member1047 (such as a syringe needle) having first tubular member end 1048which can be advanced between the articulating surfaces 1016 of thesacroiliac joint 1000 and having a second tubular member end 1049 whichremovably couples to a hub 1050. The hub 1050 can be configured toremovably couple to a syringe barrel 1051 (or other device to containand deliver an amount of radiographic contrast 1046). In the example ofa syringe barrel 1051, the syringe barrel 1051 can have an internalvolume capable of receiving an amount of the radiographic contrast 1046sufficient for outlining the articular surfaces 1016 of the sacroiliacjoint 1000, for example, under lateral fluoroscopy. A plunger 1052 canbe slidingly received within the barrel 1051 to deliver the radiographiccontrast 1046 through the tubular member 1047 into the sacroiliac joint1000. The tubular member 1047 can have a gauge ranging between about 16gauge and about 20 gauge and can further be incrementally marked on theexternal surface to allow determination of the depth at which the firstneedle end 1048 has advanced within the sacroiliac joint 1000. As thefirst needle end 1048 advances into the sacroiliac joint 1000 theradiographic dye 1046 can be delivered from within the syringe barrel1051 into the sacroiliac joint 1000 to allow visualization of thesacroiliac joint 1000 and location of the tubular needle 1047 within thesacroiliac joint 1000.

Now referring primarily to FIG. 60B, once the first tubular member end1048 has been sufficiently advanced into the sacroiliac joint 1000 andthe articular surfaces 1016 of the sacroiliac joint 1000 have beensufficiently visualized, the hub 1050 can be removed from the tubularmember 1047 leaving the tubular member 1047 fixed within the sacroiliacjoint 1000 as an initial guide for tools subsequently used to locate orplace the implant body 25 non-transversely between the articulatingsurfaces 1016 of the sacroiliac joint 1000 (e.g., locate the implantbody 25 non-transversely to the joint plane 1030 generally defined bythe articulating surfaces 1016 of the interarticular region 1044 of thesacroiliac joint 1000) or in removal of a portion of the sacroiliacjoint 1000 within the region defined by the articular surfaces 1016 togenerate an implant receiving space 1029 (see FIG. 60H). Alternately,one or more guide pins 1013 can be inserted along substantially the samepath of the tubular member 1047 for fixed engagement within thesacroiliac joint 1000 and used in subsequent steps as a guide(s).

Now referring primarily to FIG. 60C, a small incision 1053 can be madein the skin at the extra-articular recess access region 6000 aspect ofthe sacroiliac joint 1000, extending proximal and distal to the tubularmember 1047 along the line of the sacroiliac joint 1000 to provide apassage to access the interarticular space between the articulatingsurfaces 1016 (see FIG. 47B) of the sacroiliac joint 1000. Morespecifically, as can be understood from FIGS. 57-61, in one embodiment,the small incision 1053 can be made along the joint line 2019 of thesacroiliac joint 1000 in the tissue covering the extra-articular recessaccess region 6000 of the sacroiliac joint 1000. A cannulated probe 1054can be slidingly engaged with the tubular member 1047 (or guide pin1013) extending outwardly from the sacroiliac joint 1000 (while thesacroiliac joint 1000 may be shown in the figures as being substantiallylinear for illustrative purposes, it is to be understood that the normalirregular features of the sacroiliac joint have not been necessarilyremoved). The cannulated probe 1054 can have a probe body 1054 ofgenerally cylindrical shape terminating in a spatulate tip 1055 at theend advanced into the sacroiliac joint 1000. A removable cannulatedprobe handle 1056 couples to the opposed end of the probe body 1054. Thespatulate tip 1055 can be guided along the tubular needle 1047 or guidewire 1013 into the posterior portion of the sacroiliac joint 1000 andadvanced to the anterior portion of the sacroiliac joint 1000 underlateral fluoroscopic visualization. The cannulated probe handle 1056 canthen be removed providing the generally cylindrical probe body 1054extending outwardly from the sacroiliac joint 1000 through the incision1053 made in the skin. Alternatively, probe 1054 can be used to guide,advance or place a needle, guide wire or other instrument up to, near,or into the sacroiliac joint 1000.

Additionally, in particular embodiments, probe handle 1056 or theopposed end of the probe body 1054, or both, can be configured to havean interference fit or a Luer lock hub to communicate with a syringebarrel 1051 in order to advance contrast, in situ curable biocompatiblematerials, stem cells, or any other suitable materials through thecannulated probe 1054 or cannulated probe handle 1056.

Now referring primarily to FIG. 60D, a passage from the incision 1053(see FIG. 47C) to the sacroiliac joint 1000 can be generated byinserting a cannula 1057 into the incision. A soft tissue dilator 1058having a blunt end 1059 can be advanced over the probe body 1054, or aplurality of soft tissue dilators of increasing size, until the bluntend 1059 of the soft tissue dilator 1058 and the corresponding cannulaend contact the extra-articular recess access region 6000 of thesacroiliac joint 1000. The soft tissue dilator 1058 can be removed fromwithin the cannula 1057. The external surface of the cannula 1057 can besufficiently engaged with the surrounding tissue to avoid having thetissue resituate within the hollow inside of the cannula 1057. Anon-limiting embodiment of the cannula 1057 provides a tubular bodyhaving substantially parallel opposed side walls which terminate in aradius at both ends (lozenge shape) into which a plurality of differentjigs can be inserted. Alternatively, as a non-limiting example,according to particular embodiments, cannula 1057 and correspondingdilators 1058 and alignment jigs 1060 can be configured to have tubularbodies with an elliptical or circular cross section.

In some embodiments, the cannula 1057 may be additionally configured tohave within or near its walls a light source such as, for example, afiber optic or a LED light source to assist in visualization of theworking area. Also, in some embodiments, irrigation and suction tubingmay communicate with the inside passage of cannula 1057.

Now referring to FIG. 60E, a cannulated drill bit 1070 can be advancedover the probe body 1054 and within a drill guide hole 1068 (see FIGS.49A and 49B) of the first drill jig 1067. The cannulated drill bit 1070under fluoroscopic guidance can be advanced into the interarticularregion 1044 between the articulating surfaces 1016 of the sacroiliacjoint 1000 to produce a first bore 1071 (shown in broken line) to apredetermined depth. As to certain embodiments of the method, an amountof articular cartilage or other tissues from between the articularsurfaces 1016 of the sacroiliac joint 1000 can be removed sufficient toallow embodiments of the implant body 25 to be implanted in replacementof the removed articular cartilage or tissue. Because the method mayremove the degenerative articular cartilage or tissue between thearticular surfaces 1016 of the sacroiliac joint 1000, the articularsurfaces 1016 of the sacroiliac joint 1000 can remain intact orsubstantially intact allowing implant body 25 to be non-transverselylocated between the articular surfaces 1016 of the sacroiliac joint1000. Other instruments can be utilized separately or in combinationwith a cannulated drill bit 1062 for the removal of articular cartilageor tissue between articular surfaces 1016 such as: endoscopy tools, boxchisels, side cutting router bits, burs, flexible burs and bits, holesaws, curettes, lasers (such as CO₂, Nd:YAG (neodymium-dopedyttrium-aluminum-garnet), argon, and ruby), and electrosurgicalequipment employing electromagnetic energy.

In an embodiment, the cutting electrode of the electrosurgical equipmentmay be a fine micro-needle, a lancet, a knife, a wire or band loop, asnare, an energized scalpel, or the like. The electrosurgical waveformsdelivered by the cutting electrode may be set to promote two types oftissue effects, namely coagulation (temperature rises within cells,which then dehydrate and shrink) or cut (heating of cellular wateroccurs so rapidly that cells burst). The proportion of cells coagulatedto those cut can be varied, resulting in a “blended” or “mixed” effect.Additionally, a fully rectified current, or a partially rectifiedcurrent, or a fulguration current where a greater amount or lateral heatis produced can be employed to find the articular surfaces of the jointand aid in advancing a probe or guide wire into a position in betweenthe articulating surfaces. These currents can effectively degrade thecartilage and allow advance into the joint without grossly penetratingmuch beyond the cartilage.

In one embodiment, the electrical energy delivered via the cuttingelectrode can be either monopolar or bipolar and operate with highfrequency currents, for example, in the range of about 300 kHz and about1000 kHz. The waveform of the delivered electrical energy may be a puresinusoidal current waveform where the “crest factor” can be constant atabout 1.4 for every sinus waveform, and a voltage peak of approximately300 V to enable a “pure” cutting effect with the smallest possiblecoagulation effect. Alternatively, the electrical energy may bedelivered as amplitude modulated current waveforms where the crestfactor varies between 1.5 and 8, with decreasing crest factors providingless of a coagulation effect.

Now referring to FIG. 60F, as to certain embodiments of the invention,the first drill jig 1067 can be removed from within the cannula 1057 anda second drill jig 1072 can be advanced over the probe body 1054 andreceived within the cannula 1057; however, the invention is not limitedto any particular number of drill jigs and as to certain embodiments ofthe method the first drill jig 1067 can include all the required drillguide hole(s) 1068 (or slots or other configurations of the drill guide)and as to other embodiments of the method a plurality of drill jigs canbe utilized in serial order to provide all the drill guide holes 1068.As to the particular embodiment of the invention shown by the figures,the first drill jig 1067 can provide one or more additional drill guideholes 1068 which guide in relation to the first bore 1071 a second ormore cannulated drills 1062 of the same or different configuration to beinserted within and advanced into the sacroiliac joint 1000 to produce asecond bore 1073 (generally shown in broken line as 1071/1073) or aplurality of bores within the sacroiliac joint 1000 spaced apart inpredetermined pattern to allow removal of sufficient articular cartilage1016 or other tissue from the interarticular space of sacroiliac joint1000 for placement of embodiments of the sacroiliac joint implant 25within the region defined by and between the paired articular surfaces1016 of the sacroiliac joint 1000. As to certain methods of theinvention, the first drill jig 1067 or the second drill jig 1072 or aplurality of drill jigs can be utilized in serial order to remove aportion of the sacroiliac joint 1000 for generation of an implantreceiving space 1029 (see, for example, FIG. 60H). As these embodimentsof the method, articular cartilage or other tissues and sufficientsubchondral bone can be removed from between the articular surfaces 1016of the sacroiliac joint 1000 sufficient to allow placement of certainembodiments of the sacroiliac joint implant body 25. In otherembodiments, one or more transverse receiving channels 1074 aligned withthe direction of the receiving space and extending in a directionperpendicular to the joint plane 1030 can be cut into at least one ofthe articular surfaces 1016 of said sacroiliac joint 1000 sufficient toreceive certain elements of the implant body 25 including, but notlimited to one or more fins 50, as illustrated in FIG. 5A in oneembodiment of the implant body 25. The one or more transverse receivingchannels 1074 can be cut a depth into the subchondral, cortical bone orcancellous bone of the sacrum 1004 and/or ilium 1005. A transversereceiving channel 1074 in one embodiment is illustrated in FIG. 60H asdashed lines.

Now referring primarily to FIG. 60G, in a subsequent step, the lastdrill jig 1072 in the series can be removed from within the cannula 1057and a broach jig 1075 can be advanced over the probe body 1054 andsituated within the cannula 1057. The broach jig 1075 can include abroach guide hole 1076 which receives a first broach end 1077 of acannulated broach 1078 advanced over the probe body 1054. The firstbroach end 1077 can have a configuration which can be advanced into thesacroiliac joint 1000. As to certain embodiments of the method, thefirst broach end 1077 can be adapted to remove an amount of articularcartilage and other tissue from between the articular surfaces 1016within the articular region 1044 of the sacroiliac joint 1000 fornon-transverse placement of the sacroiliac joint implant body 25.Referring to FIG. 60H, in various other embodiments of the method, thecannulated broach 1078 can further remove a sufficient portion of thesacroiliac joint 1000 to generate an implant receiving space 1029 toreceive various embodiments of the sacroiliac joint implant 25, asillustrated in FIGS. 5, 9, and 12 by way of non-limiting examples. Inyet other embodiments, the cannulated broach 1078 can further remove asufficient portion of the sacroiliac joint 1000 to generate one or moretransverse receiving channels 1074 to receive one or more fins 50adapted to extend into the bone of the sacrum 1004 or the ilium 1005 invarious embodiments of the sacroiliac joint implant 25 (see FIGS. 5, 9,and 12).

Now referring primarily to FIGS. 59 and 61, the implant receiving space1029 and the sacroiliac joint implant body 25 can be configured havingrelated dimensions such that placement of the insertion element 650 ofthe sacroiliac joint implant body 25 within the implant receiving space1029 disposes the sacrum 1004 and the ilium 1005 in substantiallyimmobilized relation and substantially avoids alteration of thepositional relation of the sacrum 1004 and the ilium 1005 from thenormal condition, or avoids driving together or driving apart the sacrum1004 from the ilium 1005 outside of or substantially outside of thenormal positional relation. In an embodiment, the insertion element 650and the implant receiving space 1029 may be configured to immobilize thesacrum 1004 in relation to the ilium 1005 while maintaining thesacroiliac joint 1000 in substantially normal or substantially normalpositional relation, or to return the sacroiliac joint 1000 to asubstantially normal positional relation and thereby correct adegenerative condition of the sacroiliac joint 1000.

As a non-limiting example, configurations of an implant receiving space1029 allow embodiments of the sacroiliac joint implant body 25 to beplaced non-transversely between the articular surfaces 1016 of theextra-articular space 3007 of the sacroiliac joint 1000. While certainembodiments of the sacroiliac joint implant body 25 may only provide aninsertion element 650 which locates within a correspondingly configuredimplant receiving space 1029 to engage at least a portion of the bone ofthe ilium 1005 or sacrum 1004, the invention is not so limited, and canfurther include one or more fins 50 engaging a portion of the bone 1073of the sacrum 1004 and/or the ilium 1005.

As to those embodiments of the sacroiliac joint implant bodies 25 whichfurther include one or more fins 50, the implant receiving space 1029can further include one or more corresponding transverse receivingchannels 1074, which correspondingly allow the one or more fins 50 toextend into the bone 1073 of the sacrum 1004 or the ilium 1005 (whethersubchondral, cortical, cancellous, or the like). Alternatively, impactof the insertion plate 45 of the sacroiliac joint implant 25 into theimplant receiving space 1029 without the transverse receiving channels1074 can forcibly urge the one or more fins 50 into the bone 1073 of thesacrum 1004 and the ilium 1005. An anchor 30 members can be insertedthrough the bore 40 in the implant 25 and into the sacrum 1004 and ilium1005 to fix the location of the fixation fusion implant 25 within theimplant receiving space 1029.

Reference is now made to FIGS. 57-59. FIG. 57 is alateral-inferior-posterior view and FIG. 58 is an inferior-posteriorview of the patient's hip skeletal structure 7, and accessing theextra-articular space 3007 via an extra-articular recess access region6000. The S1 through S4 foramina can be seen at the respectiveindicators 51, S2, S3 and S4 in FIGS. 57 and 58.

Referring to FIG. 57, the delivery tool 20 has been configured such thatthe anchor arm 115 is oriented so as to deliver the anchor member 30through anchor bore 40 of the implant body 25 into the sacrum 1004 andthen optionally further into the ilium 1005. In other words, the anchor30 is inserted through the bore 40 within the attachment element 652 anddriven medial to lateral through the sacrum 1004 first and then into theimplant followed by the ilium 1005 (optional). In the embodiment of FIG.57, the anchor 30 may be a bone screw the same as or similar to an S2alar iliac (S2AI) screw. Such a screw may penetrate the sacrum 1004 justlateral to the lateral edge of the S1 foramen and just superior of thesuperior edge of the S1 foramen. Thus, the anchor 30 can enter the boneof sacrum 1004 near the first sacral foramen (S2AI trajectory) then canfurther enter the bone of the ilium 1005. The implant body 25, as withany of the implantation locations and implant bodies 25 discussed hereincan optionally be employed to be configured to serve as an attachmentpoint for structural components of a spinal support system via anattachment fitting 500 mechanically attached in an adjustable lockedengagement with the attachment element 652 of the implant body 25. Inone non-limiting example, the attachment fitting 500 may be attached toan end of a spanning element of a spinal support system such as a rod2096, as illustrated in FIG. 3.

Referring to FIG. 59, the insertion element 650 of the implant body 25may be situated within the extra-articular region 3007 in oneembodiment. Further, the implant body 25 is inserted into theextra-articular region 3007 via an extra-articular recess access region6000. As illustrated in FIG. 58, this extra-articular recess accessregion 6000 is opposite to the posterior inferior overhang 2020 of theposterior superior iliac spine 2004 from the caudal portion 1086 of thesacroiliac joint articular region 1014 and posterior inferior accessregion 2016 leading to the sacroiliac joint articular region 1044employed to implant the implant 25 in the caudal portion 1086 of thesacroiliac joint articular region 1044 in other embodiments, asdiscussed herein below.

As can be understood from FIG. 59, the insertion element 650 of theimplant body 25 is oriented in the extra-articular region 3007. In theembodiment shown in FIG. 59, in which the insertion element 650 is aninsertion plate 45, the orientation of the insertion plate 45 isgenerally coplanar with the plane of the extra-articular region 3007 andthe narrow fins 50 extend into the sacrum 1004 and ilium 1005 bonedefining each side of the extra-articular region 3007.

As illustrated in FIG. 59, in some embodiments, the insertion element650 of the implant body 25 is oriented within the extra-articular region3007 such that the longitudinal axis LAI of the insertion element 650 isgenerally perpendicular to the posterior boundary segment 3008 of theboundary 3000 of the sacroiliac joint articular region 1014. Also, thedistal end 42 of the implant body 25, when implanted in theextra-articular region 3007, points towards the anterior-inferior corner3010 of the boundary 3000 of the sacroiliac joint articular region 1014.The distal end 42 of the implant body 25 may extend across the posteriorboundary segment 3008 of the extra-articular region 3007 and into thesacroiliac joint articular region 1044. Thus, when implanting theinsertion element 650 of the implant body 25 via the extra-articularrecess access region 6000, the general direction of travel for theimplant distal end 42 is towards the anterior-inferior corner 3010, andthe insertion element 650 can be positioned substantially within theextra-articular region 3007 or, alternatively, the insertion element 650can be further advanced to also occupy a portion of the sacroiliac jointarticular region 1044.

As discussed herein above, to implant the implant body 25 in theextra-articular region 3007, the delivery tool 20 is configured in oneembodiment to drive the anchor 30 medial to lateral through the implantbore 40 into the sacrum 1004 and, optionally, further into the ilium1005. However, in some embodiments, the delivery tool 20 and implantbore 40 may have as-manufactured configurations that allow the anchor 30to be driven lateral to medial through the ilium 1005 into one or moreadditional bores 670 (see FIG. 11A).

While the preceding discussion is given in the context of the implantbody 25 being implanted non-transversely in the extra-articular space3007 of the sacroiliac joint 1000, in other embodiments, the implantbody 25 may be implanted in other locations within the sacroiliac joint1000. For example, as disclosed in U.S. patent application Ser. No.12/998,712, which is incorporated herein by reference, in someembodiments, the implant body 25 may be implanted non-transversely inthe caudal portion 1086 (see FIG. 50A) of the sacroiliac joint 1000 bythe similar procedures or steps as above described with the incision andgeneration of the passage to the superior articular portion of thesacroiliac joint 1000. The implant body 25 may also be implanted in thesacroiliac joint 1000 in such a manner so as to extend between thecranial and caudal portions, as also disclosed in U.S. patentapplication Ser. No. 12/998,712.

ii. Insertion of Insertion Element of Implant Body into ImplantReceiving Space

To begin a discussion of employing the delivery tool 20 to implant theimplant body 25 in the sacroiliac joint 1000 once the implant receivingspace 1029 has been created, reference is made to FIGS. 601, 57, 58, and59. As shown in FIGS. 601, 57, 58, and 59, once the implant receivingspace 1029 has been created as discussed above with respect to FIGS.60A-60H, the implant body 25 can be supported off of the distal end 120of the implant arm 110 of the delivery tool 20 and positioned such thatthe distal end 42 of the implant body 25 (specifically the insertionplate 45) begins to enter the sacroiliac joint articular region 1044 viathe extra-articular recess access region 6000. In entering thesacroiliac joint space, insertion element 650 of the implant body 25 isoriented generally parallel to, and aligned with the contour of thearticulating surfaces 1016 of the sacroiliac joint 1000.

In various embodiments the contour of the insertion plate 45 may bealigned along the direction of the articulating surfaces 1016 definingthe extra-articular recess of the sacroiliac joint 1000. In oneembodiment, the implant receiving space 1029 may be prepared to receivea planar insertion plate 45, as illustrated in FIG. 60I. In anotherembodiment, the insertion element 650 may be custom contoured to conformwith the existing contour of the articulating surfaces 1016 based onmedical images of the sacroiliac joint 1000 obtained prior to producingthe implant body 20. In an additional embodiment, the insertion element650 may be produced so as to be deformable by the surgeon to adjust thecontour of the insertion element 650 to approximately match the contourof the articulating surfaces 1016. In another additional embodiment, theinsertion element 650 may be a threaded cylindrical element as describedpreviously herein. In this other additional embodiment, the threadedcylindrical element may be twisted into a cylindrical bore formed in thejoint space.

Referring back to FIG. 60I, the longitudinal axis LCA₂ of the implantarm 110 of the delivery tool 20 has a generally anterior trajectory thatis located within the joint plane 1030. Alternatively, according toparticular embodiments, as a non-limiting example, the longitudinal axisLCA₂ of the implant arm 110 of the delivery tool 20 can have atrajectory which can be defined as being generally lateral or, inparticular embodiments, generally posterior. In some embodiments, whenthe implant body 25 is being delivered into the joint space, the implantarm 110 can be said to be at least one of generally superior or cephaladto the sciatic notch.

As illustrated in FIGS. 60J and 53, the insertion element 650 is fullyreceived in the prepared sacroiliac space 1029 such that the plane ofthe insertion element 650 is oriented generally parallel to, and alignedwith, the sacroiliac joint line 2019 (i.e., the plane of the insertionelement 650 is generally located within the joint plane 1030), and theimplant body's fins 50 are generally transverse to the joint plane 1030and, in some embodiments, have even entered the bone material formingthe sacrum and ilium articular surfaces of the sacroiliac joint (see,e.g., FIGS. 50C and 50D). As can be understood from FIG. 50J, thelongitudinal axis IBA of the implant body 25 and the longitudinal axisLCA2 of the implant arm 110 may be coaxially aligned with each other andgenerally located in the sacroiliac joint plane 1030.

In addition, FIGS. 57 and 58 illustrate the sleeve 100 now received inthe collar 165 of the anchor arm 115. As can be understood from FIGS.60K, 57, and 58, the distal end of the sleeve 100 may extend through anincision in the patient's soft tissue such that the distal end of thesleeve 100 is positioned generally against the lateral surface of theilium 1005. The longitudinal axis of the sleeve 100 and collar 165 ofthe anchor arm 115 can be understood to be generally coaxially alignedwith the longitudinal axis of the bore 40 of the implant body 25.

Referring now to FIG. 59, the sacroiliac joint space boundary 3000 isdefined along the sacrum 1004 and outlines the sacroiliac jointarticular region 1044. The implant 25 positioned for implantation withinthe extra-articular space 3007 of the sacroiliac joint 1000. As shown inFIG. 59, the sacroiliac joint space boundary includes an inferiorboundary segment 3002, an anterior boundary segment 3004, a superiorboundary segment 3006, and a posterior boundary segment 3008. Theinferior boundary segment 3002 is immediately adjacent, and extendsalong, the sciatic notch 2024.

The inferior boundary segment 3002 and anterior boundary segment 3004intersect to form an anterior-inferior corner 3010. The anteriorboundary segment 3004 and superior boundary segment 3006 intersect toform an anterior-superior corner 3012. The superior boundary segment3006 and posterior boundary segment 3008 intersect to form asuperior-posterior corner 3014. The posterior boundary segment 3008 andposterior inferior access region 2016 intersect to form asuperior-posterior corner 3016 of the posterior inferior access region2016. The inferior boundary segment 3002 and posterior inferior accessregion 2016 intersect to form an inferior-posterior corner 3018 of theposterior inferior access region 2016.

The inferior boundary segment 3002 extends between corners 3010 and3018. The anterior boundary segment 3004 extends between corners 3010and 3012. The superior boundary segment 3006 extends between corners3012 and 3014 and provides an access into the cranial portion 1087 ofthe sacroiliac joint. The posterior boundary segment 3008 extendsbetween corners 3014 and 3016. The posterior inferior access region 2016extends between corners 3016 and 3018 and provides an access into thecaudal region 1086 of the sacroiliac joint. The posterior boundarysegment 3008 separates articular region 1044 and extra-articular region3007, which includes the sacral fossa on the sacrum 1004 and thecorresponding iliac tuberosity on the ilium 1005 and defined by theextra-articular region boundary 3009.

As shown in FIG. 59, the insertion element 650 of the implant body 25 isinserted via the implant arm 110 of the delivery tool 20 into theextra-articular space 3007 of the sacroiliac joint 1000. The implant 25enters the extra-articular recess access region 6000, and is furtheradvanced into the extra-articular space 3007 of the sacroiliac joint1000 in an orientation such that the implant arm 110 and implant plate45 are in the joint plane 1030 (see, for example, FIGS. 601-60J). Thus,the distal end 42 of the implant body 25 is heading generallyperpendicular to, and towards, the anterior boundary segment 3004. Thus,when implanting the insertion element 650 of the implant body 25 via theextra-articular recess access region 6000, the general direction oftravel for the implant distal end 42 is towards the anterior-inferiorcorner 3010, and the insertion element 650 can be positionedsubstantially within the extra-articular region 3007 or, alternatively,the insertion element 650 can be further advanced to also occupy aportion of the sacroiliac joint articular region 1044.

iii. Insertion of Anchor

FIG. 58 is a posterior-inferior view of the hip region 1002 of thepatient 1001. As can be understood from FIGS. 60L and 58, the anchor 30is positioned in the lumen of the sleeve 100. A driving tool 105 (e.g.,screw driver) is extended through the lumen of the sleeve 100 so thedistal end of the tool 105 is engaged with a proximal end of the anchormember 30 (e.g., screw). As shown in FIG. 60M, the tool 105 is used todrive the anchor 30 distally through into the bore 40 of the implant 25generally transverse to the joint line plane 1030 and into the bone ofthe sacrum 1004, in this embodiment. As a result, as indicated in FIG.60N, the implant assembly 15 formed of the implant body 25 and anchor 30is secured at the implantation site such that the implant body 25 islocated in the prepared space 1029 of the sacroiliac joint space, andthe anchor 30 extends through into the bore 40 of the implant 25 intothe bone of the sacrum 1005 and into generally transverse to the jointspace plane 1030 and optionally into the bone of the ilium 2004, asillustrated in FIG. 60N. The tool 105 and sleeve 100 can be removed fromthe anchor arm collar 165, and the incision associated with the sleeve100 can be closed. Additionally, tool 105 can be a cutting tool 105(e.g., drill bit, hole punch, or etc.) which can used in similar stepsas above describe to remove bone or other tissues in the path whereanchor 30 is to be placed. As indicated in FIG. 60O, the distal end ofthe implant arm 110 is decoupled from the proximal end of the implant 25and removed. The incision associated with the implant arm can be closed.

As illustrated in FIG. 60P, in certain embodiments, the implant body 25can be configured to have more than one implant bore 40 to receiveadditional anchors 30A. The anchors 30 and 30A prevent migration of theimplant body 25 within the joint space. The anchors 30 and 30A also candraw the ilium and sacrum together about the implant body 25, increasingthe sturdiness of the fixation of the implant 25 in the joint space, asdemonstrated by the anchor 30A in FIG. 60P. Where the anchor 30 extendsthrough the implant bore 40 and into the bone of both the sacrum 1004and ilium 1005, the anchor 30 can be used to drawn the articularsurfaces 1016 of the sacroiliac joint 1000 against the external surfacesof the insertion element 350 of the implant body 25. With the insertionelement 350 implanted in the sacroiliac joint, the healing processeswill cause the surfaces 1016 to fuse together about the insertionelement 350.

FIG. 61 is a posterior view of the implantation area 1029 and theimplant body 25 implanted within the implantation area 1029. In thisview, the insertion element 650 situated in the joint space is obscuredby the attachment element 652. As can be understood from FIG. 61, theextra-articular recess access region 6000 and implanted in theextra-articular space 3007 of the sacroiliac joint 1000. The anchor 30can be understood to have been driven into the implant bore 40transversely to the joint plane 1030 via a route in the sacrum 1004 thatavoids contact with vascular and neurological structures, therebyavoiding potentially life threatening injury to such structures. Theability to blindly, yet safely, drive the anchor member 30 into theimplant bore 40 while the implant 25 is hidden in the joint space ismade possible by the cooperating configurations of the implant body 25and the delivery tool 20. Specifically, the longitudinal axis LCA1 ofthe anchor arm 165 is coaxially aligned with the longitudinal axis BA ofthe implant bore 40 when the implant body 25 is supported off of theimplant arm 110 of the delivery tool 20, thereby making it possible tosafely drive the anchor 30 through the implant bore 40 and into theilium 1005 bone and/or sacrum bone 1004 when the implant body 25 ishidden in the joint space on account of being delivered to the jointspace via the delivery tool 20.

Anchor trajectory and placement may be guided and confirmed with imagingstudies before the end of the surgical procedure or afterwards. Forexample, a surgeon may use fluoroscopy (and/or arteriography) to obtainan anteroposterior view, lateral view, an inlet view, an outlet-obliqueview, Judet views of the pelvis, an internal (obturator) oblique view, aFerguson view, an external (iliac) oblique view or other relevant viewsand further use radiographic boney landmarks such as the superimposedgreater sciatic notches, superimposed iliac cortical densities or alarslope, sacral promontory, first sacral endplate, sacral foramina,arcuate sacral lines, iliopectineal line, ilioishial line, acetabularteardrop lines bony corridors of S1 or S2, superimposed acetabula,ventral and dorsal surfaces of the sacrum, etc.; or using an angiogramto identify vascular structures such as the superior gluteal artery,internal iliac artery and vein, iliolumbar vein, etc.

b. Implantation Via Intra-Articular Approach

i. Preparation of Implant Receiving Space

Now that the relevant anatomical landmarks have been identified withrespect to FIGS. 44A-46B, the methodology associated with employing anyof the above-described delivery tools 20 in implanting any of theabove-described implant bodies 25 in the sacroiliac joint 1000 of apatient 1001 can be discussed. In doing so, reference will be made toFIGS. 47A-47P, which are each a step in the methodology and illustratedas the same transverse cross section taken in along a plane extendingmedial-lateral and anterior posterior along section line 99-99 in FIG.46B. In this cross section, articular surfaces 1016 are covered by athick layer of articular cartilage with a joint space existing betweenthem, the FIGS. 47A-47P are simplified for illustrative purposes and donot show these features to scale. Now referring primarily to FIG. 47A,an embodiment of the method can include the step of placing a patientunder sedation prone on a translucent operating table (or other suitablesurface). The sacroiliac joint 1000 can be locally anesthetized to allowfor injecting a radiographic contrast 1046 (as a non-limiting example,ISOVIEW 300 radiographic contrast) under fluoroscopic guidance into theinferior aspect of the sacroiliac joint 1000 to outline the articularsurfaces 1016 of the sacroiliac joint 1000) defined between the sacrum1004 and ilium 1005, the sacroiliac joint 1000 having an interarticularregion 1044. Injection of the radiographic contrast 1046 within thesacroiliac joint 1000 can be accomplished utilizing a tubular member1047 (such as a syringe needle) having first tubular member end 1048which can be advanced between the articulating surfaces 1016 of thesacroiliac joint 1000 and having a second tubular member end 1049 whichremovably couples to a hub 1050. The hub 1050 can be configured toremovably couple to a syringe barrel 1051 (or other device to containand deliver an amount of radiographic contrast 1046). In the example ofa syringe barrel 1051, the syringe barrel 1051 can have an internalvolume capable of receiving an amount of the radiographic contrast 1046sufficient for outlining the articular surfaces 1016 of the sacroiliacjoint 1000, for example, under lateral fluoroscopy. A plunger 1052 canbe slidingly received within the barrel 1051 to deliver the radiographiccontrast 1046 through the tubular member 1047 into the sacroiliac joint1000. The tubular member 1047 can have a gauge ranging between about 16gauge and about 20 gauge and can further be incrementally marked on theexternal surface to allow determination of the depth at which the firstneedle end 1048 has advanced within the sacroiliac joint 1000. As thefirst needle end 1048 advances into the sacroiliac joint 1000 theradiographic dye 1046 can be delivered from within the syringe barrel1051 into the sacroiliac joint 1000 to allow visualization of thesacroiliac joint 1000 and location of the tubular needle 1047 within thesacroiliac joint 1000.

Now referring primarily to FIG. 47B, once the first tubular member end1048 has been sufficiently advanced into the sacroiliac joint 1000 andthe articular surfaces 1016 of the sacroiliac joint 1000 have beensufficiently visualized, the hub 1050 can be removed from the tubularmember 1047 leaving the tubular member 1047 fixed within the sacroiliacjoint 1000 as an initial guide for tools subsequently used to locate orplace the implant body 25 non-transversely between the articulatingsurfaces 1016 of the sacroiliac joint 1000 (e.g., locate the implantbody 25 non-transversely to the joint plane 1030 generally defined bythe articulating surfaces 1016 of the interarticular region 1044 of thesacroiliac joint 1000) or in removal of a portion of the sacroiliacjoint 1000 within the region defined by the articular surfaces 1016 togenerate an implant receiving space 1029 (see FIG. 47H). Alternately,one or more guide pins 1013 can be inserted along substantially the samepath of the tubular member 1047 for fixed engagement within thesacroiliac joint 1000 and used in subsequent steps as a guide(s).

Now referring primarily to FIG. 47C, a small incision 1053 can be madein the skin at the posterior superior (or as to certain embodimentsinferior) aspect of the sacroiliac joint 1000, extending proximal anddistal to the tubular member 1047 along the line of the sacroiliac joint1000 to provide a passage to access the interarticular space between thearticulating surfaces 1016 (see FIG. 47B) of the sacroiliac joint 1000.More specifically, as can be understood from FIGS. 45A-45B, in oneembodiment, the small incision 1053 can be made along the joint line2019 of the sacroiliac joint 1000 in the tissue covering the posteriorinferior access region 2016 of the sacroiliac joint articular region1044. A cannulated probe 1054 can be slidingly engaged with the tubularmember 1047 (or guide pin 1013) extending outwardly from the sacroiliacjoint 1000 (while the sacroiliac joint may be shown in the figures asbeing substantially linear for illustrative purposes, it is to beunderstood that the normal irregular features of the sacroiliac jointhave not been removed). The cannulated probe 1054 can have a probe body1054 of generally cylindrical shape terminating in a spatulate tip 1055at the end advanced into the sacroiliac joint 1000. A removablecannulated probe handle 1056 couples to the opposed end of the probebody 1054. The spatulate tip 1055 can be guided along the tubular needle1047 or guide wire 1013 into the posterior portion of the sacroiliacjoint 1000 and advanced to the anterior portion of the sacroiliac joint1000 under lateral fluoroscopic visualization. The cannulated probehandle 1056 can then be removed providing the generally cylindricalprobe body 1054 extending outwardly from the sacroiliac joint 1000through the incision 1053 made in the skin. Alternatively, probe 1054can be used to guide, advance or place a needle, guide wire or otherinstrument up to, near, or into the sacroiliac joint 1000.

Additionally, in particular embodiments, probe handle 1056 or theopposed end of the probe body 1054, or both, can be configured to havean interference fit or a Luer lock hub to communicate with a syringebarrel 1051 in order to advance contrast, in situ curable biocompatiblematerials, stem cells, or any other suitable materials through thecannulated probe 1054 or cannulated probe handle 1056.

Now referring primarily to FIG. 47D, a passage from the incision 1053(see FIG. 47C) to the sacroiliac joint 1000 can be generated byinserting a cannula 1057 into the incision. A soft tissue dilator 1058having a blunt end 1059 can be advanced over the probe body 1054, or aplurality of soft tissue dilators of increasing size, until the bluntend 1059 of the soft tissue dilator 1058 and the corresponding cannulaend contact the posterior aspect of the sacroiliac joint 1000. Morespecifically, as can be understood from FIGS. 44A-46B, in oneembodiment, the ends of the dilator 1058 and cannula 1057 contact thejoint line 2019 of the sacroiliac joint 1000 at the posterior inferioraccess region 2016 of the sacroiliac joint articular region 1044. Thesoft tissue dilator 1058 can be removed from within the cannula 1057.The external surface of the cannula 1057 can be sufficiently engagedwith the surrounding tissue to avoid having the tissue resituate withinthe hollow inside of the cannula 1057. A non-limiting embodiment of thecannula 1057 provides a tubular body having substantially parallelopposed side walls which terminate in a radius at both ends (lozengeshape) into which a plurality of different jigs can be inserted.Alternatively, as a non-limiting example, according to particularembodiments, cannula 1057 and corresponding dilators 1058 and alignmentjigs 1060 can be configured to have tubular bodies with an elliptical orcircular cross section.

In some embodiments, the cannula 1057 may be additionally configured tohave within or near its walls a light source such as, for example, afiber optic or a LED light source to assist in visualization of theworking area. Also, in some embodiments, irrigation and suction tubingmay communicate with the inside passage of cannula 1057.

Now referring primarily to FIGS. 48A-48C, a cannula alignment jig 1060can be advanced over the probe body 1054 (or guide pins 1013) andreceived within the cannula 1057. Substantially, identical cross hairs1063, 1064 can be disposed on the upper jig surface 1065 and the lowerjig surface 1066. Alignment of the cross hairs 1063, 1064 under x-raywith the sacroiliac joint 1000 can confirm that the cannula 1057 hasproper orientation in relation to the paired articular surfaces 1016 ofthe sacroiliac joint 1000. The cannula 1057 properly oriented with thepaired articular surfaces 1016 can then be disposed in fixed relation tothe sacroiliac joint by placement of fasteners through the cannula 1057into the sacrum 1004 or the ilium 1005.

Now referring to FIGS. 49A and 49B, a first drill jig 1067 can beadvanced over the probe body 1054 (or guide pins 1013) and receivedwithin the cannula 1057. The probe body 1054 (or guide pins 1013)extending outwardly from the sacroiliac joint 1000 passes through adrill guide hole 1068 of the first drill jig 1067 (or a plurality ofguide pins 1013 can extend through a corresponding plurality of guidepin holes 1069). The drill guide hole 1068 can take the form of acircular hole as shown in the Figures, a slot, or other configuration torestrict the movement of the drill bit 1062 (see FIG. 47E) within thedrill jig 1060 and provide a guide for a drill bit 1062 in relation tothe sacroiliac joint 1000. Guide pin holes 1069 can receive guide pinswhich can be positioned between the articular surfaces 1016 of thesacroiliac joint 1000 to demarcate the zone of desired treatment or safeworking zones while using, for example, lateral fluoroscopy. As anon-limiting example, a first guide pin 1013 can be advanced through afirst guide pin hole 1069, or alternatively a guide pin 1013 is firstinserted into the sacroiliac joint 1000 and subsequently a guide jig1067 is advanced over the guide pin 1013, the first guide pin 1013 canenter near inferior end 2022 of the posterior inferior access region2016 of the sacroiliac joint articular region 1044 via the sacroiliacjoint line 2019 to border a portion of the greater sciatic notch 2008thereby allowing a medical person, computer guided surgical system, orother observer to more easily highlight under x-ray a border whichshould not be crossed during the procedure due to the presence of nerveand other structures. Additionally, as a non-limiting example, firstguide pin 1013 can configured as an electrode, insulated from theoperator and the patient's soft tissues, and may be connected to amonitor to signal to an operator or surgeon when implant body 25,configured with a stimulating electrode (NM), as discussed below, comesinto contact with first guide pin. Similarly, a second guide pin 1013can be placed in another guide pin hole 1069 to demarcate a second limitto a desired zone of treatment, or safe working zone. For example, asecond guide pin 1013 can enter near the superior end 2018 of theposterior inferior access region 2016 of the sacroiliac joint articularregion 1044 via the sacroiliac joint line 2019 to be positioned toborder an area of the sacroiliac joint 1000 such as a transition zonebetween the extra-articular 3007 and the interarticular region 1044which, for example, has been highlighted by contrast material as abovedescribed.

Referring to FIGS. 49C-49K, a cannula 1057 may be used to facilitateaccess to the surgical region during a procedure to implant the implantassembly 25 (not shown). In one embodiment, the cannula 1057 may be usedin conjunction with a sacroiliac joint repair procedure via a knownsurgical access region including, but not limited to, the posteriorinferior access region 2016 as illustrated in FIGS. 49C-49K. The cannula1057 may include a cannula body 1057H forming a wall enclosing aninternal volume 1057J, which opens to a proximal opening 1057A and adistal opening 1057B. Upon insertion of the cannula 1057 within thesurgical access region, the internal volume 1057J may be maintained,thereby functioning as an opening through which surgical instruments,appliances, fasteners, and any other associated surgical equipment orsupplies may be inserted or removed and through which the surgicalprocedure may be visually monitored.

The outer surface of the cannula body 1057H may include one or morecontoured regions or projections to enhance the close fit of the cannula1057 between the skeletal structures surrounding the surgical accessregion 2016. The outer surface of the body 1057H may form a cannulasacral contour 1057C on one side and may additionally form a cannulailiac contour 1057D on a side opposite to the cannula sacral contour1057C. The cannula 1057 may also include a distal projection 1057E whichextends distally beyond the cannula sacral contour 1057C and may beshaped to fit within a portion of the greater sciatic notch 2008 (seeFIG. 49I). In addition, the outer distal surface of the cannula body1057H may form a PSIS contact area 1057F to enhance the fit of theportion of the cannula 1057 contacting the posterior superior iliacspine (PSIS) 2004 (see FIG. 49G).

The cannula body 1057H may further define one or more additional boresconfigured to reversibly receive handles and/or fasteners used tosituate the cannula within the surgical region and/or to reversiblyreceive fasteners used to fix the cannula in place within the surgicalregion during the surgical procedure. The cannula body 1057H may definea fastener bore 1057K passing through the cannula body 1057H from theouter surface into the internal volume 1057J of the cannula 1057. Thecannula bore may open at one end to a cannula fastener bore proximalopening 1057G, which may be in communication with the internal volume1057J of the cannula 1057. The cannula bore may also open at an oppositeend to a cannula fastener bore distal opening 1057L which may be furtherconfigured to permit a fastener 1057Z to i) extend generallyperpendicular to the cannula PSIS contact area 1057F; and/or, ii) be ina divergent relation relative to distal projection 1057E. Furthermore,the cannula 1057 may have a handle 1057Y extending from the cannula body1057H for inserting, removing, and/or otherwise manipulating the cannula1057 during a surgical procedure. As illustrated in FIG. 49C, the handle1057Y may be reversibly attached to the cannula body 1057 via a handlebore 1057M formed with the cannula body 1057H. The handle bore 1057M maybe provided with fastener features including, but not limited to,threads, that may cooperatively engage corresponding fastener featuresat a distal end 1057N of the handle 1057Y in order to implement thereversible attachment of the handle 1057Y to the cannula 1057.

Referring again to FIGS. 49C to 49K, a surgical procedure employing thecannula 1057 may be conducted using a method described herein below. Acannula 1057 may be positioned near a sacroiliac joint line 2019 and inan area including the posterior inferior access region 2016 such thatthe sacroiliac joint line 2019 may be visible and/or accessible via acannula proximal opening 1057A, as illustrated in FIG. 49H. The cannula1057 may be further positioned to align the distal extension 1057E witha portion of the greater sciatic notch 2008, as illustrated in FIG. 49I.The cannula 1057 may be further positioned to align the cannula PSIScontact area 1057F with a portion of a posterior superior iliac spine2004 as illustrated in FIG. 49G. The cannula 1057 may then be disposedin fixed relation to the sacroiliac joint by placement of fasteners1057Z through the cannula 1057 into the sacrum 1004 or the ilium 1005,as illustrated in FIG. 49I.

Now referring to FIG. 47E, a cannulated drill bit 1070 can be advancedover the probe body 1054 and within a drill guide hole 1068 (see FIGS.49A and 49B) of the first drill jig 1067. The cannulated drill bit 1070under fluoroscopic guidance can be advanced into the interarticularregion 1044 between the articulating surfaces 1016 of the sacroiliacjoint 1000 to produce a first bore 1071 (shown in broken line) to adetermined depth. As to certain embodiments of the method, an amount ofarticular cartilage or other tissues from between the articular surfaces1016 of the sacroiliac joint 1000 can be removed sufficient to allowembodiments of the implant body 25 to be implanted in replacement of theremoved articular cartilage or tissue. Because the method removes thedegenerative articular cartilage or tissue between the articularsurfaces 1016 of the sacroiliac joint 1000, the articular surfaces 1016of the sacroiliac joint 1000 can remain intact or substantially intactallowing implant body 25 to be non-transversely located between thearticular surfaces 1016 of the sacroiliac joint 1000. Other instrumentscan be utilized separately or in combination with a cannulated drill bit1062 for the removal of articular cartilage or tissue between articularsurfaces 1016 such as: endoscopy tools, box chisels, side cutting routerbits, burs, flexible burs and bits, hole saws, curettes, lasers (such asCO₂, Nd:YAG (neodymium-doped yttrium-aluminum-garnet), argon, and ruby),and electrosurgical equipment employing electromagnetic energy.

In an embodiment, the cutting electrode of the electrosurgical equipmentmay be a fine micro-needle, a lancet, a knife, a wire or band loop, asnare, an energized scalpel, or the like. The electrosurgical waveformsdelivered by the cutting electrode may be set to promote two types oftissue effects, namely coagulation (temperature rises within cells,which then dehydrate and shrink) or cut (heating of cellular wateroccurs so rapidly that cells burst). The proportion of cells coagulatedto those cut can be varied, resulting in a “blended” or “mixed” effect.Additionally, a fully rectified current, or a partially rectifiedcurrent, or a fulguration current where a greater amount or lateral heatis produced can be employed to find the articular surfaces of the jointand aid in advancing a probe or guide wire into a position in betweenthe articulating surfaces. These currents can effectively degrade thecartilage and allow advance into the joint without grossly penetratingmuch beyond the cartilage.

In one embodiment, the electrical energy delivered via the cuttingelectrode can be either monopolar or bipolar and operate with highfrequency currents, for example, in the range of about 300 kHz and about1000 kHz. The waveform of the delivered electrical energy may be a puresinusoidal current waveform where the “crest factor” can be constant atabout 1.4 for every sinus waveform, and a voltage peak of approximately300 V to enable a “pure” cutting effect with the smallest possiblecoagulation effect. Alternatively, the electrical energy may bedelivered as amplitude modulated current waveforms where the crestfactor varies between 1.5 and 8, with decreasing crest factors providingless of a coagulation effect.

Now referring to FIG. 47F, as to certain embodiments of the invention,the first drill jig 1067 can be removed from within the cannula 1057 anda second drill jig 1072 can be advanced over the probe body 1054 andreceived within the cannula 1057; however, the invention is not limitedto any particular number of drill jigs and as to certain embodiments ofthe method the first drill jig 1067 can include all the required drillguide hole(s) 1068 (or slots or other configurations of the drill guide)and as to other embodiments of the method a plurality of drill jigs canbe utilized in serial order to provide all the drill guide holes 1068.As to the particular embodiment of the invention shown by the Figures,the first drill jig 1067 can provide one or more additional drill guideholes 1068 which guide in relation to the first bore 1071 a second ormore cannulated drills 1062 of the same or different configuration to beinserted within and advanced into the sacroiliac joint 1000 to produce asecond bore 1073 (generally shown in broken line as 1071/1073) or aplurality of bores within the sacroiliac joint 1000 spaced apart inpredetermined pattern to allow removal of sufficient articular cartilage1016 or other tissue from the interarticular space of sacroiliac joint1000 for placement of embodiments of the sacroiliac joint implant 25within the region defined by and between the paired articular surfaces1016 of the sacroiliac joint 1000. As to certain methods of theinvention, the first drill jig 1067 or the second drill jig 1072 or aplurality of drill jigs can be utilized in serial order to remove aportion of the sacroiliac joint 1000 for generation of an implantreceiving space 1029 (see, for example, FIG. 47H). As these embodimentsof the method, articular cartilage or other tissues and sufficientsubchondral bone can be removed from between the articular surfaces 1016of the sacroiliac joint 1000 sufficient to allow placement of certainembodiments of the sacroiliac joint implant body 25. In otherembodiments, one or more transverse receiving channels 1074 aligned withthe direction of the receiving space and extending in a directionperpendicular to the joint plane 1030 can be cut into at least one ofthe articular surfaces 1016 of said sacroiliac joint 1000 sufficient toreceive certain elements of the implant body 25 including, but notlimited to one or more fins 50, as illustrated in FIG. 5A in oneembodiment of the implant body 25. The one or more transverse receivingchannels 1074 can be cut a depth into the subchondral, cortical bone orcancellous bone of the sacrum 1004 and/or ilium 1005. A transversereceiving channel 1074 in one embodiment is illustrated in FIG. 47H asdashed lines.

Now referring primarily to FIG. 47G, in a subsequent step, the lastdrill jig 1072 in the series can be removed from within the cannula 1057and a broach jig 1075 can be advanced over the probe body 1054 andsituated within the cannula 1057. The broach jig 1075 can include abroach guide hole 1076 which receives a first broach end 1077 of acannulated broach 1078 advanced over the probe body 1054. The firstbroach end 1077 can have a configuration which can be advanced into thesacroiliac joint 1000. As to certain embodiments of the method, thefirst broach end 1077 can be adapted to remove an amount of articularcartilage and other tissue from between the articular surfaces 1016within the articular region 1044 of the sacroiliac joint 1000 fornon-transverse placement of the sacroiliac joint implant body 25. As toother embodiments of the method, the cannulated broach 1078 can furtherremove a sufficient portion of the sacroiliac joint 1000 to generate animplant receiving space 1029 to receive various embodiments of thesacroiliac joint implant 25 having a flattened elongate insertion plate45, as illustrated in FIGS. 5, 9, and 12 in various embodiments by wayof non-limiting examples. In yet other embodiments, the cannulatedbroach 1078 can further remove a sufficient portion of the sacroiliacjoint 1000 to generate one or more transverse receiving channels 1074 toreceive one or more fins 50 adapted to extend into the bone of thesacrum 1004 or the ilium 1005 in various embodiments of the sacroiliacjoint implant 25 (see FIGS. 5, 9, and 12).

To generate the one or more transverse receiving channels 1074 toreceive one or more fins 50 or keels of an implant 25, the jointpreparation tool assembly 2300 described above in conjunction with FIGS.259 and 260 may be employed, as illustrated in FIGS. 261A-261D.Referring primarily to FIG. 261A, a trial tool assembly 4022, which maybe an example of the trial tool assembly 2302 of FIGS. 259 and 260,having an implant trial 4024 at a distal end of the assembly 4022 may bedelivered into the sacroiliac joint articular region 1044 of a patient.The trial tool assembly 4022 may be guided into the articular region1044 by a guide wire (not shown) that was previously delivered into thejoint by previously described methods. In particular, the guide wire maybe received within a bore that extends from a distal end to a proximalend of the implant trial 4024. The implant trial 4024 may be deliveredwithin the joint plane 1030 such that the planar top and bottom surfaces4026 are parallel to the joint plane 1030 and the opposite side surfaces4028 of the implant trial 4024 are perpendicular to the joint plane1030.

The implant trial 4024 may be forcibly delivered into the articularregion 1044 by using a hammer or mallet to strike an impact plate (notshown) at a proximal end of the joint preparation tool assembly 4020.And, in certain embodiments, a trial impact rod assembly (not shown) maybe used in conjunction with the trial tool assembly 4022 to providestiffness during the forceful delivery of the implant trial 4024 withinthe articular region 1044.

The implant trial 4024 is used to determine an appropriate fit of animplant. So, implant trials 4024 of increasingly larger size may bedelivered into the articular region 1044 until an implant trial 4024 ischosen that appropriately fits the top and bottom surfaces 4026 of theimplant trial 4024 against the articular surfaces of the articularregion 1044.

Referring primarily to FIG. 261B, which depicts the implant trial 4024positioned within the articular region 1044, a cutting tool 4030, whichmay be an example of the cutting tool 2304 of FIGS. 259 and 260, may beslidingly engaged with a shaft 4032 of the trial tool assembly 4022 andtranslated distally on the shaft 4032. As seen in FIG. 261B and asdescribed previously in conjunction with FIGS. 259 and 260, the cuttingtool 4030 is guided along the shaft 4032 in a single orientation suchthat it will be guided within a channel (not shown) on the top surface4026 of the implant trial 4024. The channel is configured to guide thecutting tool 4030 such that a cutting element 4034 of the cutting tool4030 extends generally perpendicular to the top surface 4026 of theimplant trial 4024. Thus, as seen in FIG. 261C, as the cutting element4034 advances distally into the channel of the implant trial 4024 andwithin the articular region 1044, the cutting element 4034 extends andcuts into the articular surface of either the sacrum 1004 or the ilium1005. A reciprocating motion may be employed.

While, as seen in FIG. 261C, the cutting element 4034 extends and cutsinto the ilium 1005 during a distal stroke of the cutting tool 4030, theprocess may be similarly performed with respect to the sacrum 1004.Alternatively, a cutting tool 4030 with dual-cutting elements 4034 maybe employed to deliver simultaneous and opposing cuts into both thesacrum 1004 and the ilium 1005. In such an embodiment of the jointpreparation tool assembly 4020 with dual-cutting elements 4034 (and,thus, dual-channels in the implant trial 4024) the individual cuttingelements 4034 may be the same or different. The individual cuttingelements 4034 may, for example, be different types and configurations ofcutting elements 4034 since the ilium 1005 is a generally harder bonethan the sacrum 1004. Additionally, cutting tools 4030 with increasinglylarger cutting elements 4034 may be employed such that initial cuts aresmaller and of a shallower depth into the articular surfaces whilesubsequent cuts are larger and of a deeper depth into the articularsurfaces of the sacrum 1004 and ilium 1005.

After employing the joint preparation tool 4020 to make appropriatekeel-cuts or fin-cuts, as seen in FIG. 261D, the tool 4020 may beremoved from the articular region 1044 leaving one or more channels 4036that match an implant to be delivered into the joint 1000.

Now referring primarily to FIGS. 50A-50D, the implant receiving space1029 and the sacroiliac joint implant body 25 can be configured havingrelated dimension relations such that placement of the insertion plate45 of the sacroiliac joint implant body 25 within the implant receivingspace 1029 disposes the sacrum 1004 and the ilium 1005 in substantiallyimmobilized relation and substantially avoids alteration of thepositional relation of the sacrum 1004 and the ilium 1005 from thenormal condition, or avoids driving together or driving apart the sacrum1004 from the ilium 1005 outside of or substantially outside of thenormal positional relation. In an embodiment, the insertion plate 45 andthe implant receiving space 1029 may be configured to immobilize thesacrum 1004 in relation to the ilium 1005 while maintaining thesacroiliac joint 1000 in substantially normal or substantially normalpositional relation, or to return the sacroiliac joint 1000 to asubstantially normal positional relation and thereby correct adegenerative condition of the sacroiliac joint 1000.

As a non-limiting example, configurations of an implant receiving space1029 allow embodiments of the sacroiliac joint implant body 25 to beplaced non-transversely between the caudal portions 1086 of thearticular surfaces 1016 of the sacroiliac joint 1000. While certainembodiments of the sacroiliac joint implant body 25 may only provide aninsertion plate 45 which locates within a correspondingly configuredimplant receiving space 1029 to engage at least a portion of the bone ofthe ilium 1005 or sacrum 1004, the invention is not so limited, and canfurther include one or more fins 50 engaging a portion of the bone 1073of the sacrum 1004 and/or the ilium 1005.

As to those embodiments of the sacroiliac joint implant bodies 25 whichfurther include one or more fins 50, the implant receiving space 1029can further include one or more corresponding transverse receivingchannels 1074, which correspondingly allow the one or more fins 50 toextend into the bone 1073 of the sacrum 1004 or the ilium 1005 (whethersubchondral, cortical, cancellous, or the like). Alternatively, impactof the insertion plate 45 of the sacroiliac joint implant 25 into theimplant receiving space 1029 without the transverse receiving channels1074 can forcibly urge the one or more fins 50 into the bone 1073 of thesacrum 1004 and the ilium 1005. An anchor 30 members can be insertedthrough the bore 40 in the implant 25 and into the sacrum 1004 and ilium1005 to fix the location of the fixation fusion implant 25 within theimplant receiving space 1029.

While the preceding discussion is given in the context of the implantbody 25 being implanted non-transversely in the caudal portion 1086 ofthe sacroiliac joint 1000, in other embodiments, the implant body 25 maybe implanted in other locations within the sacroiliac joint 1000. Forexample, as disclosed in U.S. patent application Ser. No. 12/998,712,which is incorporated herein by reference, in some embodiments, theimplant body 25 may be implanted non-transversely in the cranial portion1087 (see FIG. 50A) of the sacroiliac joint 1000 by the similarprocedures or steps as above described with the incision and generationof the passage to the superior articular portion of the sacroiliac joint1000. The implant body 25 may also be implanted in the sacroiliac joint1000 in such a manner so as to extend between the cranial and caudalportions, as also disclosed in U.S. patent application Ser. No.12/998,712.

ii. Insertion of Insertion Element of Implant Body into ImplantReceiving Space

To begin a discussion of employing the delivery tool 20 to implant theimplant body 25 in the sacroiliac joint 1000 once the implant receivingspace 1029 has been created, reference is made to FIGS. 47I, 51A, 51Band 52. FIG. 51A is generally the same view as FIG. 45A, and FIG. 51B isan enlarged view of the hip region of FIG. 51A. FIG. 52 is generally thesame enlarged view as FIG. 44B. As shown in FIGS. 47I, 51A, 51B and 52,once the implant receiving space 1029 has been created as discussedabove with respect to FIGS. 47A-47H, the implant body 25 can besupported off of the distal end 120 of the implant arm 110 of thedelivery tool 20 and positioned such that the distal end 42 of theimplant body 25 (specifically the insertion plate 45) begins to enterthe sacroiliac joint articular region 1044 via the posterior inferioraccess region 2016, which is described in detail above with respect toFIGS. 44A-46B. As can be understood from FIGS. 51A-52, in entering thesacroiliac joint space, the implant body 25 is oriented such that theplane of the insertion plate 45 is oriented generally parallel to, andaligned with, the sacroiliac joint line 2019. The longitudinal axis LCA2of the implant arm 110 of the delivery tool 20 has a generally anteriortrajectory that is located within the joint plane 1030. Alternatively,according to particular embodiments, as a non-limiting example, thelongitudinal axis LCA2 of the implant arm 110 of the delivery tool 20can have a trajectory which can be defined as being generally lateralor, in particular embodiments, generally posterior. In some embodiments,when the implant body 25 is being delivered into the joint space, theimplant arm 110 can be said to be at least one of generally superior orcephalad to the sciatic notch.

FIG. 53 is the same view as FIG. 52, except the insertion plate 45 ofthe implant body 25 has now been fully inserted into the prepared space1029 in the sacroiliac joint 1000. As illustrated in FIGS. 47J and 53,the insertion plate 45 is fully received in the prepared sacroiliacspace 1029 such that the plane of the insertion plate 45 is orientedgenerally parallel to, and aligned with, the sacroiliac joint line 2019(i.e., the plane of the insertion plate 45 are generally located withinthe joint plane 1030), and the implant body's fins 50 are generallytransverse to the joint plane 1030 and, in some embodiments, have evenentered the bone material forming the sacrum and ilium articularsurfaces of the sacroiliac joint (see, e.g., FIGS. 50C and 50D). As canbe understood from FIG. 47J, the longitudinal axis IBA of the implantbody 25 and the longitudinal axis LCA2 of the implant arm 110 may becoaxially aligned with each other and generally located in thesacroiliac joint plane 1030.

In addition, FIG. 53 illustrates the sleeve 100 is now received in thecollar 165 of the anchor arm 115. As can be understood from FIGS. 47Kand 53, the distal end of the sleeve 100 may extend through an incisionin the patient's soft tissue such that the distal end of the sleeve 100is positioned generally against the lateral surface of the ilium 1005.The longitudinal axis of the sleeve and collar of the anchor arm can beunderstood to be generally coaxially aligned with the longitudinal axisof the bore 40 of the implant body 25.

FIG. 54 is generally the same view as FIG. 53, except the ilium 1005 isremoved to show the sacroiliac joint space boundary 3000 defined alongthe sacrum 1004 and outlining the sacroiliac joint articular region1044, the implant 25 positioned for implantation within the sacroiliacjoint articular region 1044. As shown in FIG. 54, the sacroiliac jointspace boundary includes an inferior boundary segment 3002, an anteriorboundary segment 3004, a superior boundary segment 3006, and a posteriorboundary segment 3008. The inferior boundary segment 3002 is immediatelyadjacent, and extends along, the sciatic notch 2024.

The inferior boundary segment 3002 and anterior boundary segment 3004intersect to form an anterior-inferior corner 3010. The anteriorboundary segment 3004 and superior boundary segment 3006 intersect toform an anterior-superior corner 3012. The superior boundary segment3006 and posterior boundary segment 3008 intersect to form asuperior-posterior corner 3014. The posterior boundary segment 3008 andposterior inferior access region 2016 intersect to form asuperior-posterior corner 3016 of the posterior inferior access region2016. The inferior boundary segment 3002 and posterior inferior accessregion 2016 intersect to form an inferior-posterior corner 3018 of theposterior inferior access region 2016.

The inferior boundary segment 3002 extends between corners 3010 and3018. The anterior boundary segment 3004 extends between corners 3010and 3012. The superior boundary segment 3006 extends between corners3012 and 3014 and provides an access into the cranial portion 1087 ofthe sacroiliac joint. The posterior boundary segment 3008 extendsbetween corners 3014 and 3016. The posterior inferior access region 2016extends between corners 3016 and 3018 and provides an access into thecaudal region 1086 of the sacroiliac joint. The posterior boundarysegment 3008 separates articular region 1044 and extra-articular region3007, which includes the sacral fossa on the sacrum 1004 and thecorresponding iliac tuberosity on the ilium 1005 and defined by theextra-articular region boundary 3009.

As shown in FIG. 54, the insertion plate 45 of the implant body 25 isinserted via the implant arm 110 of the delivery tool 20 into the caudalregion 1086 of the sacroiliac joint articular region 1044. As shown viathe insertion plate 45 and implant arm 110 shown in solid lines, in oneembodiment, the implant 25 enters the posterior inferior access region2016, and is further advanced into the caudal region 1086 of thesacroiliac joint articular region 1044, in an orientation such that theimplant arm 110 and implant plate 45 are in the joint plane 1030 (see,for example, FIGS. 47I-47J) and the longitudinally extending edge 3050of the implant plate 45 next to the inferior boundary segment 3002 isgenerally parallel to, and immediately adjacent to, the inferiorboundary segment 3002. Thus, the distal end 42 of the implant is headinggenerally perpendicular to, and towards, the anterior boundary segment3004.

As shown in FIG. 54 via the insertion plate 45 and implant arm 110 shownin dashed lines, in one embodiment, the insertion plate 45 enters theposterior inferior access region 2016, and is further advanced into thecaudal region 1086 of the sacroiliac joint articular region 1044, in anorientation such that the implant arm 110 and plane of the insertionplate 45 are in the joint plane 1030 (see, for example, FIGS. 47I-47J)and the longitudinally extending edge 3050 of the insertion plate 45next to the inferior boundary segment 3002 is somewhere between beinggenerally parallel to the inferior boundary segment 3002 (as illustratedby the solid-lined implant 25 in FIG. 54) or forming an angle AJ withthe inferior boundary segment 3002 of up to approximately 50 degrees.Thus, the distal end 42 of the implant shown in dashed lines can be saidto head anywhere from generally perpendicular to, and towards, theanterior boundary segment 3004 to heading generally towards thesuperior-anterior corner 3012, or points in between.

In one embodiment, the insertion plate 45 may be first directed into thejoint space as illustrated by the solid-lined implant body 25 in FIG. 54after which the implant body 25 is rotated within the joint space to bepositioned somewhere between, and including, the angled positiondepicted by the dashed-lined implant body 25. In other embodiments, theinsertion plate 45 may be first directed into the joint space asillustrated by the dashed-lined implant body 25 in FIG. 54 after whichthe implant body 25 is rotated within the joint space to be positionedsomewhere between, and including, the parallel position depicted by thesolid-lined implant body 25.

iii. Insertion of Anchor

FIG. 55 is a posterior-inferior view of the hip region 1002 of thepatient 1001, wherein the soft tissue 1003 surrounding the skeletal hipbones is shown in dashed lines. As can be understood from FIGS. 47L and55, the anchor 30 is positioned in the lumen of the sleeve 100. Adriving tool 105 (e.g., screw driver) is extended through the lumen ofthe sleeve 100 so the distal end of the tool 105 is engaged with aproximal end of the anchor member 30 (e.g., screw). As shown in FIG.47M, the tool 105 is used to drive the anchor 30 distally through intothe bore 40 of the implant 25 generally transverse to the joint lineplane 1030 and into the bone of the sacrum 1004, in this embodiment. Asa result, as indicated in FIG. 47N, the implant assembly 15 formed ofthe implant 25 and anchor 30 is secured at the implantation site suchthat the implant 25 is located in the prepared space 1029 of thesacroiliac joint space, and the anchor 30 extends through into the bore40 of the implant 25 into the bone of the sacrum 1005 and into theimplant bore 40 generally transverse to the joint space plane 1030. Thetool 105 and sleeve 100 can be removed from the anchor arm collar 165,and the incision associated with the sleeve 100 can be closed.Additionally, tool 105 can be a cutting tool 105 (e.g., drill bit, holepunch, or etc.) which can used in similar steps as above describe toremove bone or other tissues in the path where anchor 30 is to beplaced. As indicated in FIG. 47O, the distal end of the implant arm 110is decoupled from the proximal end of the implant 25 and removed. Theincision associated with the implant arm can be closed.

In other embodiments, illustrated in FIG. 47P, the anchor 30 may enter abore 40 situated in a more medial position relative to the insertionplate 45; the implant body 25 of this embodiment is illustrated in FIG.9. In this embodiment, the anchor 30 may enter the bore 40, penetratethe bone of the sacrum 1004, pass through a second bore formed withinthe insertion plate 45 and aligned with the first bore 40, and furtherpenetrate the bone of the ilium 1005.

As illustrated in FIG. 47Q, in certain embodiments, the implant body 25can be configured to have more than one implant bore 40 to receiveadditional anchors 30A and 30B. The anchors 30, 30A, and 30B preventmigration of the implant body 25 within the joint space. The anchors 30,30A, and 30B also can draw the ilium and sacrum together about theimplant body 25, increasing the sturdiness of the fixation of theimplant in the joint space, as demonstrated by the anchor 30 in FIG. 47Pand by anchor 30B in FIG. 47Q. Where the anchor 30 extends through theimplant bore 40 and into the bone of both the sacrum 1004 and ilium1005, the anchor 30 can be used to drawn the articular surfaces 1016 ofthe sacroiliac joint 1000 against the external surfaces of the insertionplate 45 of the implant body 25. With the insertion plate 45 implantedin the sacroiliac joint, the healing processes will cause the surfaces1016 to fuse together about the insertion plate 45.

FIG. 56 is a posterior view of the implantation area and the implantbody 25 implanted within the implantation area. In this view, theinsertion plate 45 situated in the joint space is obscured by theattachment element 652. As can be understood from FIG. 56, the implantbody 25 can be seen positioned in the posterior inferior access region2016 and implanted in the caudal area of the sacroiliac joint space. Theanchor 30 can be understood to have been driven into the implant bore 40transversely to the joint plane 1030 via a route in the ilium 1005 thatavoids contact with vascular and neurological structures, therebyavoiding potentially life threatening injury to such structures. Theability to blindly, yet safely, drive the anchor member 30 into theimplant bore 40 while the implant 25 is hidden in the joint space ismade possible by the cooperating configurations of the implant body 25and the delivery tool 20. Specifically, the longitudinal axis LCA1 ofthe anchor arm 165 is coaxially aligned with the longitudinal axis BA ofthe implant bore 40 when the implant body 25 is supported off of theimplant arm 110 of the delivery tool 20, thereby making it possible tosafely drive the anchor 30 through the implant bore 40 and into theilium 1005 bone and/or sacrum bone 1004 when the implant body 25 ishidden in the joint space on account of being delivered to the jointspace via the delivery tool 20.

FIGS. 62-91 are various views of the sacroiliac joint 1000 andassociated skeletal structures of a patient 1001 illustrating theposition and orientation of the delivery tool 20 and/or implant body 25in various embodiments during implantation of the implant body 25 withinthe extra-articular space of the sacroiliac joint 1000 using variousembodiments of a method, as described above.

Optionally, according to particular embodiments, various systems orparts thereof, kits and/or methods described herein may further include(where applicable, the use thereof) one or more of the following: aradio-frequency (RF) or optical machine-readable representation of datarelating to the object to which it is attached (e.g., a barcode or aradio-frequency identification (RFID) tag) and/or a compatiblescanner/reader; sterilization tray; sterilization caddy; sterilizationcassette; sterile packaging; manual or powered orthopedic surgicalinstrument; cerclage applier; awl; rod reducer or persuader; rod orplate bender (e.g., including deflection or plastic deformation meansparticularly adapted for changing the configuration of a rod or plate toa prescribed configuration or to a configuration which substantiallyconforms to a specific application site, e.g., some particular bonestructure); drill bit; bone mill; drill; drill brace; drill guide;broach; abrader; curette; orthopedic burr; corkscrew; countersink; pinor cable crimper; wire or cable cutter; prosthesis driver; extractor;file; fork; needle holder; forceps; impactor; bending or contouringinstrument; compression instrument and/or distraction instrument (e.g.,cyclable or incrementable; e.g., wherein the instrument causes apressing together or a separation (or spreading) of either 1) a firsttool and a second tool, 2) a first portion and a second portion of animplant assembly, and/or 3) a first bone to which a first portion of theinstrument is applied and a second bone to which a second portion of theinstrument is applied, so as to adjust and maintain the bones in adesired positional relationship during a portion of the surgicalprocedure and/or healing process (e.g., the compression or distractionmechanism may remain as part of the implant assembly during the wholeperiod of treatment)); orthopedic knife; passer; wire or cable passer;socket positioner; probe; punch; socket pusher; bone rasp; bonescrapper; osteotome; reamer; rongeur; resector; orthopedic surgicalscissors; screwdriver; hollow mill set; bone skid; implant trial;channeling instrument; staple driver; bone screw starter; surgicalstripper; tamp; bone tap; trephine; wire twister; wrench;torque-limiting wrench; counter torque tool; slap hammer assembly;clamp; cutter stop (e.g., a stop or guard which limits the advance ormovement of a cutting device to prevent cutting too deeply into the bodyportion being cut); adjustable drill bit stop; rasp stop; trial stop;inserter stop (e.g., a stop or guard which limits the advance ormovement of an inserter device to prevent insertion of an implant toodeeply into the body portion being treated); hammer; mallet; suture(applier); ligature (applier); elastic band (applier); clip (applier);reciprocating or oscillating cutter (e.g., a saw; e.g., wherein the sawis alternately moved backward and forward in a linear motion which isgenerally parallel to the toothed edge; e.g., wherein the cutter isrotatably reciprocated about a fixed point along its longitudinal axis);rotary cutter; lancet; spring-driven lancet; cylindrical saw (e.g.,circular or disc-like in shape); shear-type cutter (e.g., wherein thecutting is accomplished by the action of two cutting blades which whenmoved toward each other about a fixed or floating pivot point cooperateto effect a cut); joining means between a first tool or system componentand second tool or system component, the joining means configured in afixed condition, an adjustably fixed condition, or a movable condition;bone cement applicator; prosthesis insertor or extractor (e.g.,including force transferal means specifically adapted to place or removea bone repairing means through forceful contact or collision in whichmomentum is transferred from the force transferal means to thereparation means; e.g., including a restrained movable mass (e.g., aslide hammer) wherein the insertion or removing means includes a rodwhich has a means extending therefrom for attaching to said rod thereparation means and a sliding weight which is moved along said rod toimpact upon a cooperating anvil-like member to provide a force forinserting or removing the reparation means); gauging or measuring device(e.g., wherein a physical characteristic of the bone repair means or acharacteristic of the bone itself is subjected to assessment todetermine how the reparation process should be altered to effect aproper repair); wiring aid (e.g., wherein the bone repair means isparticularly adapted for the application of or tensioning of a slender,flexible, string-like piece of material about or through bone and/or aportion of an implant assembly); probang (e.g., wherein a probang isused to remove material from a tool lumen, musculoskeletal joint space,implant receiving space, bone tunnel or passageway); conduit; lightapplication apparatus (e.g., wherein the applicator includes flexible,optically transparent fiber material for directing a light or analogousrays along a restricted path); a clevis; and a detent.

Optionally, the systems and/or implant assemblies described herein mayfurther include one or more of the following: an enclosed space adaptedfor holding a gas or liquid (e.g., a fluid filled chamber); elastic bodycapable of recovering its shape after being compressed, bent, orstretched (e.g., a spring); a first approximately spherical memberadapted to fit and move within an approximately spherical cavity of asecond member (e.g., a ball and socket means); magnetic means capable ofattracting or repelling ferromagnetic material; separable componentswhich are interchangeable with one another for assembly into units ofdifferent size, complexity or function (e.g., modular portions of animplant assembly); tubular members which slide one within another (e.g.,a telescoping means); mechanism having a cam surface and a cam follower;damping element (adapted to absorb or dissipate forces imposed on theimplant assembly or a part thereof); retaining ring; locking ring;stepped surface (e.g., grooves forming a zig-zag patterned surface);adjustable portion (e.g., including an elongated support shaft includingmeans to alter a longitudinal dimension); electrical means to promoteingrowth of living bone tissue; a device for controlling the flow of afluid (e.g., a valve); fluid actuator including means which uses fluidenergy to initiate or produce an intended effect or function of animplant assembly or portion thereof; mechanical actuator including meanswhich uses mechanical energy to initiate or produce an intended effector function of an implant assembly or portion thereof; electricalactuator (e.g., bioelectrical (e.g., myoelectric, etc.) actuatorincluding electrical or electromotive properties of living tissue toproduce electrical energy used in operating or regulating an implantassembly or portion thereof); a clevis; and a detent.

V. Implant Embodiments

FIGS. 262A-279J illustrate various implant embodiments for fusing asacroiliac joint. In particular, FIGS. 262A-262G illustrate a particularembodiment of a sacroiliac joint implant 4999. FIGS. 263A-263Jillustrate another particular embodiment of a sacroiliac joint implant5000. FIGS. 264A-264J illustrate another particular embodiment of asacroiliac joint implant 5002. FIGS. 265A-265J illustrate anotherparticular embodiment of a sacroiliac joint implant 5004. FIGS.266A-266J illustrate another particular embodiment of a sacroiliac jointimplant 5006. FIGS. 267A-267J illustrate another particular embodimentof a sacroiliac joint implant 5008. FIGS. 268A-268J illustrate anotherparticular embodiment of a sacroiliac joint implant 5010. FIGS.269A-269J illustrate another particular embodiment of a sacroiliac jointimplant 5012. FIGS. 270A-270J illustrate another particular embodimentof a sacroiliac joint implant 5014. FIGS. 271A-271J illustrate anotherparticular embodiment of a sacroiliac joint implant 5016. FIGS.272A-272J illustrate another particular embodiment of a sacroiliac jointimplant 5018. FIGS. 273A-273J illustrate another particular embodimentof a sacroiliac joint implant 5020. FIGS. 274A-274J illustrate anotherparticular embodiment of a sacroiliac joint implant 5022. FIGS.275A-275J illustrate another particular embodiment of a sacroiliac jointimplant 5024. FIGS. 276A-276J illustrate another particular embodimentof a sacroiliac joint implant 5026. FIGS. 277A-277J illustrate anotherparticular embodiment of a sacroiliac joint implant 5028. FIGS.278A-278J illustrate another particular embodiment of a sacroiliac jointimplant 5030. FIGS. 279A-279J illustrate another particular embodimentof a sacroiliac joint implant 5032.

The implants of FIGS. 262A-279J may include various features fromimplants described in this application, as well as any of theapplications incorporated by reference herein. For instance, theimplants may include an implant body, a distal end, a proximal end,keels extending between the distal and proximal ends, and a passagewayextending transversely through or across the implant body. The implantbody may further include surface textures, passageways through thekeels, flares and/or ridges on any or all surfaces of the keels, amongother features. The keels may include passageways of different shapes,sizes, and arrangements, as indicated in the figures. As an example, theimplants shown in FIGS. 262A-279J may include similar features to theimplants described in U.S. patent application Ser. No. 14/447,612, andmay be used with the delivery tools described in that application.Additionally or alternatively, the implants of this section may includecertain ornamental features as shown in FIGS. 262A-279J.

The foregoing merely illustrates the principles of the invention.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.It will thus be appreciated that those skilled in the art will be ableto devise numerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of theinvention and are thus within the spirit and scope of the presentinvention. From the above description and drawings, it will beunderstood by those of ordinary skill in the art that the particularembodiments shown and described are for purposes of illustrations onlyand are not intended to limit the scope of the present invention.References to details of particular embodiments are not intended tolimit the scope of the invention.

What is claimed is:
 1. A method of fusing a sacroiliac joint andproviding an anchor for a spinal support system, the method comprising:a) providing a sacroiliac joint fusion and anchoring system comprising:i) an implant assembly comprising: 1) an implant body comprising; aninsertion element comprising: an insertion plate with a proximalinsertion element end, a distal insertion element end, a medial face, alateral face opposite the medial face, and a first bore extending acrossand through the medial and lateral faces of the insertion plate, thefirst bore extending to the distal insertion element end to define anopen distal end; and  one or more elongate fins, wherein each of the oneor more elongate fins projects substantially perpendicularly outwardfrom the medial face or the lateral face of the insertion plate andextending longitudinally between the proximal insertion element end andthe distal insertion element end; and  an attachment elementmechanically attached to the proximal insertion element end; wherein theattachment element comprises an anchor fitting formed within theattachment element or mechanically attached to the attachment element;and 2) an anchor; and ii) a delivery tool comprising: 1) an implant armcomprising a distal implant arm end releasably coupled to the proximalinsertion element end of the implant body; and 2) an anchor armcomprising a proximal anchor arm end coupled to the implant arm and adistal anchor arm end opposite to the proximal anchor arm end, whereinthe distal anchor arm end distally ends in a sleeve configured to guidethe anchor within a predetermined range of anchor insertiontrajectories; b) preparing an implant receiving space via anextra-articular recess access region of the sacroiliac joint, whereinthe implant receiving space extends from a posterior portion of thesacroiliac joint toward an anterior portion of the sacroiliac joint byremoving an amount of articular cartilage and other tissues from betweenan ilium articular surface and a sacrum articular surface defining thejoint space; c) situating the insertion element of the implant bodynon-transversely within the implant receiving space such that: i) theattachment fitting projects in a medial direction from a joint line ofthe sacroiliac joint; ii) the anchor fitting is situated over a regionof the sacrum just lateral to the lateral edge of the S1 foramen andjust superior to the superior edge of the S1 foramen; d) inserting adriving tool through a lumen of the sleeve of the anchor arm such that adistal end of the driving tool is engaged with a proximal end of theanchor; e) operating the driving tool to insert the anchor on a S2AItrajectory, wherein the distal end of the anchor passes through theanchor fitting, enters the sacrum near a first sacral foramen in amedial to lateral direction and further enter the ilium; and f)detaching the distal end of the delivery tool from the implant body. 2.The method of claim 1, further comprising inserting one or moreadditional fasteners through additional bores formed within theattachment member or insertion member, the one or more additionalfasteners chosen from one or more of: a) a first additional fastenerinserted through the ilium in a lateral to medial direction such that adistal tip of the first additional fastener is situated within a blindbore formed within a lateral face of the insertion element; b) a secondadditional fastener inserted through the ilium in a lateral to medialdirection such that a distal tip of the second additional fastener isdriven through an open bore formed transversely through the insertionelement and into the sacrum adjacent to a medial face of the insertionelement; c) a third additional fastener inserted through the sacrum in amedial to lateral direction such that a distal tip of the thirdadditional fastener is situated within a blind bore formed within amedial face of the insertion element; d) a fourth additional fastenerinserted through the sacrum in a medial to lateral direction such that adistal tip of the fourth additional fastener is situated within the openbore formed transversely through the insertion element and into theilium adjacent to a medial face of the insertion element; e) a fifthadditional fastener inserted through an additional open bore formedthrough the attachment element in a fifth fastener direction chosen fromany one of: a lateral to medial direction into the sacrum, a medial tolateral direction into the sacrum, a medial to lateral direction intothe sacrum and ilium, a cranial direction into the sacrum, and a caudaldirection into the sacrum.
 3. The method of claim 1, wherein the implantassembly further comprises an attachment fitting attached to theattachment element, and wherein the method further comprises attaching asupport element of a spinal support system to the attachment fitting. 4.The method of claim 1, further comprising inserting a distal end of theanchor through the anchor fitting and through the sacrum in a medial tolateral direction such that the distal end of the anchor is positionedwithin the first bore of the insertion element.